'FRAME-EX´ - FRAME Running for EXercise in Children and Young People With Disabilities - a Study Protocol for a Quasi-Experimental Single-Arm Trial
Phase: NA
Conditions: Physical Disability, Physical Activity, Physical Function, Quality of Life, Participation
Sponsor: Odense University Hospital

`FRAME-EX´ - FRAME Running for EXercise in children and 
young people with disabilities - a study protocol for a 
quasi‑experimental single‑arm trial 
 
Tina Udemark Pasgaard1, 2, Camilla Marie Larsen3, 4 Andreas Jørgensen3, 4, Helle Mätzke Rasmussen5, Jan Lexell6, Lars 
Breum Christiansen4 and Anders Holsgaard-Larsen1, 2  
1 Department of Clinical Research, University of Southern Denmark, Denmark 
2 Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark 
3 Health Sciences Research Centre, UCL University College, Odense, Denmark 
4 Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark 
5 Research Center for Integrated Healthcare, Region of Southern Denmark, University Hospital of Southern Denmark, Aabenraa, Denmark 
6 Rehabilitation Medicine Research Group, Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden 
 
Last updated: April 14, 2026 
______________________________________________________________________________________ 
Background 
Children and young people with physical disabilities, including cerebral palsy (CP) and muscular 
dystrophy, are less physically active and socially engaged than their typically developing peers (1, 
2). Reduced levels of daily physical activity (3), may contribute to poorer health, reduced fitness, and 
an increased risk of secondary musculoskeletal and cardiorespiratory impairments (4). These 
secondary complications can initiate or reinforce a negative cycle of further deconditioning, 
diminished participation, and reduced quality of life. Over time, such trajectories contribute to 
reduced life expectancy, with respiratory illness being the leading cause of death among individuals 
with severe physical disabilities (5, 6). Evidence suggests, that many of these adverse health 
trajectories may be preventable, or at least reversible, through regular participation in physical 
activity, which has consistently been associated with improved quality of life in children and 
adolescents with disabilities (7, 8). For children and young people with moderate to severe mobility 
limitations, opportunities for engaging in independent running or cycling are often inaccessible. This 
underscores the need for alternative, enjoyable, and developmentally appropriate modes of physical 
activity.  
Frame Running, an adaptive sport developed in Denmark in 1991, offers such an opportunity. Using 
a three‑wheeled frame equipped with a saddle and handlebars, but no pedals, athletes can walk or run 
using their feet while supported by the frame. Frame Running has gained substantial popularity 
among children and young people with CP, as it provides both recreational and competitive 
participation for individuals with considerable walking limitations (9).  

Despite its growing use, Frame Running remains underexplored in the scientific literature. To date, 
only a limited number of published studies have examined this activity, with a subset focusing on 
health‑related impacts and physiological outcomes. One previous intervention study, conducted 
without a control group, reported that a 12‑week, research-initiated Frame Running program 
delivered twice weekly led to improvements in cardiorespiratory fitness and peripheral muscle 
function in children and young adults with CP (10). Additionally, a cross-sectional study (11) and a 
qualitative interview study (12) reported positive influences on psychosocial well-being and self-
reported quality of life, respectively. 
No study to date has evaluated the outcomes of Frame Running in pragmatic, real‑world settings, 
where training occurs as part of everyday practice in community sports clubs. This limits the 
generalizability of existing findings, most of which stem from researcher‑initiated interventions with 
protocol standardization. Currently, one multicenter randomized controlled trial (RCT)(13) and two 
feasibility studies are published (14, 15) both focusing primarily on cardiovascular fitness through 
more standardized, research-initiated interventions that are only partially individualized. 
Understanding how children and young people experience and respond to Frame Running in routine 
community sports environments is essential for informing future clinical recommendations, program 
implementation, and adaptive sports development. 
Given these knowledge gaps, there is a clear need for studies that examine the impact of Frame 
Running under real‑world conditions, with particular attention to functional ability, participation, and 
quality of life.  
Aim and Research Objective 
The overall aim of this project is to examine changes in functional ability, participation and quality 
of life following a pragmatic Frame Running intervention in children and young people with physical 
disabilities. 
Research objective: 
 Investigate changes in the primary outcome measure; functional ability using the Mobility 
domain of the Pediatric Evaluation of Disability Inventory – Computer Adaptive Test 
(PEDI‑CAT) (16), and a series of secondary outcome measures on mobility capacity, physical 
endurance, performance of everyday activities, and health-related quality of life in children 
and young people with physical disabilities,  

 
Methods 
Findings from the study will be reported according to the relevant EQUATOR checklists (17). This 
protocol is prepared in line with the SPIRIT checklist (18). The clinical intervention study will be 
registered in ClinicalTrials.gov, and any important protocol modifications will be documented in the 
registry and reported in subsequent publications.  
 
Study design 
The study employs a quasi‑experimental single‑arm design consisting of a 12‑week low‑intensity 
control period followed by a 12‑week moderate‑to‑high intensity Frame Running intervention period. 
The design reflects careful consideration of ethical issues and participant well‑being, particularly 
given the heterogeneity of functional ability among children and adolescents with physical 
disabilities. Although randomized controlled trials (RCTs) are conventionally regarded as the gold 
standard for causal inference, an RCT was deemed neither ethically nor practically feasible, as the 
required group homogeneity would likely exclude children with greater impairments, reduce equity 
in participation, and limit generalizability. Recruitment challenges within minority groups further 
support the use of a pragmatic, inclusive design. 
To strengthen internal validity, a rolling inclusion procedure is applied to ensure that both control and 
intervention periods are represented across all seasons. Comparing differential change scores between 
the control and intervention periods (Δcontrol vs. Δintervention) helps mitigate potential maturation 
effects, seasonal variation, and learning effects associated with repeated testing. 
The overall FRAME-EX project follows a mixed‑methods approach, integrating quantitative and 
qualitative components to address the overarching aim. The conceptual framing is informed by the 
Medical Research Council (MRC) guidance on complex interventions (19), with emphasis on 
mechanisms of change and contextual influences. Although the overall FRAME‑EX project includes 
an embedded qualitative component, the present study protocol focuses exclusively on the 
quantitative evaluation. Qualitative data will be collected as part of the broader project but are not 
analysed within the scope of this study. 
Within the MRC framework, the current evaluation therefore concentrates on: 

i. 
Refining the intervention theory and underlying assumptions informed by prior 
feasibility work 
ii. 
Conducting the quantitative impact evaluation of functional outcomes 
iii. 
Preparing for future implementation and dissemination based on accumulated 
evidence. 
Setting 
The study is conducted in collaboration with four Danish athletics clubs offering structured Frame 
Running training: Odense Atletik GF, Randers Freja Atletik, Kolding KFUM Atletik og Motion, and 
Parasport Frederiksberg. Training takes place on outdoor tracks and/or indoor facilities, providing 
year‑round accessibility. Athletes typically train 1–2 times per week for approximately 60 minutes 
under the supervision of experienced coaches. 
Training is guided by a standardized manual co‑developed by Frame Running coaches, Frame 
Running sports consultants, and the research team, ensuring consistency across sites while remaining 
grounded in established club practices. The program is delivered by experienced coaches who have 
been introduced to the manual’s structure and progression principles. Training quality and 
implementation are supported through ongoing dialogue and collaborative supervision between 
coaches, sports consultants, and the research team, thereby maintaining fidelity without imposing a 
researcher‑driven or laboratory‑controlled intervention model. 
Participants are included once they have joined the club and provided informed consent. All data 
collection takes place on‑site during regular training sessions to reduce participant burden and 
enhance ecological validity. 
Participants 
Eligible participants are children and young people aged 8–18 years with a diagnosis of CP or another 
condition causing physical disability. Participants may have some prior Frame Running experience, 
such as informal use or occasional training, but must not have taken part in structured, organized, or 
performance-oriented Frame Running training within the past 12 weeks. They must be able to propel 
the Frame Running bike forward independently and be able to understand and follow instructions 
related to Frame Running activities. 

Exclusion criteria are: Severe visual and/or cognitive impairments that would compromise safe 
participation, and known medical conditions that could limit or contraindicate involvement in the 
study (e.g., significant cardiovascular or pulmonary disease). 
Sample size 
Sample size estimation is based on the primary outcome measure the PEDI-CAT Mobility domain. 
Following Shore et al.(20), the standard deviation for this outcome measure is assumed to be 7.7 
points. For this study a clinically meaningful change is estimated as half of the difference between 
children classified in GMFCS levels III (58.1) and IV (49.9), corresponding to 4.1 points. Using a 
two‑sided α of 0.05, 80% power, and the standard formula for detecting a mean difference in a 
continuous outcome, the required sample size is estimated to be 28 participants. To account for 
potential drop‑out and maintain adequate statistical power, a minimum of 35 participants will be 
recruited. 
Recruitment process 
Participants are recruited through the four participating athletics clubs, schools and municipal 
paediatric rehabilitation services. Potential participants are identified when joining a club or by 
contacting the research team via a contact form on the project website. Written study information is 
provided by the principal investigator (TUP), followed by oral information before obtaining informed 
consent. Written informed consent is obtained from participants (if aged ≥ 14 years) and/or their legal 
guardians. 
Recruitment follows a rolling inclusion procedure to balance seasonal variation and align with natural 
club enrolment. Recruitment will continue from March 2026 until at least 35 participants are included. 
 
Intervention 
The study consists of a controlled 24‑week intervention period divided into a 12‑week control period 
followed by a 12‑week intervention period. Both periods use the newly developed Frame Running 
training manual (21), which categorizes exercises by intensity and difficulty: green exercises 
represent low intensity/low complexity, whereas yellow/red exercises indicate moderate to high 
intensity and greater complexity. 
Control period (12 weeks) 

During the control period, participants may engage in Frame Running familiarization activities. These 
activities are limited to a maximum of one session per week at the athletics club. Each session may 
last up to 60 minutes and focuses solely on becoming comfortable with the Frame Runner, including 
basic handling and introductory movement patterns performed exclusively at green (low‑intensity) 
exercises. The purpose of this period is both to ensure sufficient familiarity with the equipment and 
the club environment, and to provide a low‑intensity comparison phase against which changes 
observed during the subsequent higher‑intensity intervention can be evaluated. No additional Frame 
Running training outside the scheduled weekly session is permitted. 
Intervention period (12 weeks) 
During the intervention period, participants complete two weekly training sessions at moderate to 
high intensity. At least one 60‑minute session per week must take place at the athletics club under the 
supervision of an experienced coach. The second 60-minute weekly session may be completed at 
home. 
Training follows the progression structure outlined in the exercise training manual, incorporating 
yellow and red exercises to achieve moderate-to-high physiological and technical challenge. Each 
session includes a structured warm‑up, targeted technical skill development, endurance and speed 
intervals, and participation‑oriented activities. Adjustments to intensity and activity selection are 
permitted within the manual’s boundaries to accommodate functional ability and ensure safety. 
Figure 1 provides a design overview. 
Figure 1. Design overview 
 
Figure 1. Overview of assessment time points: T0 = baseline before the control period; T1 = baseline before the intervention period; T2 = 
end‑of‑intervention follow‑up; T3 = 6‑month post‑intervention follow‑up; and T4 = 12‑month post‑intervention follow‑up. Registration of activities 
includes both the participant‑reported training diary and the coach‑reported trainer log. 
 

Data collection, outcomes and analysis 
Quantitative data 
Quantitative data will be collected through standardized questionnaires and physical performance 
tests. All quantitative outcomes will be assessed at three time points: 
 Baseline prior to the control period (T0) 
 Follow-up prior to the intervention period (T1) 
 Follow‑up at the end of the intervention period (T2) 
In addition, all questionnaires will be administered at two extended follow‑up time points: 
 Six‑month after T2 (T3) 
 Twelve‑month after T2 (T4) 
This measurement schedule enables comparison of change during the low‑intensity control period 
and during the moderate‑to‑high intensity intervention period, consistent with the quasi‑experimental 
single arm trial design.  
Primary outcome 
The primary outcome is functional mobility assessed using the Mobility domain of the Pediatric 
Evaluation of Disability Inventory – Computer Adaptive Test (PEDI‑CAT). The PEDI‑CAT is a 
digital assessment tool designed to evaluate functional performance in children across several 
domains, including daily activities, mobility, and social/cognitive functioning. In this study, only the 
PEDI‑CAT Mobility domain is used as the primary outcome measure. It provides standardized scores 
based on age‑referenced item response theory, ensuring sensitivity to clinically meaningful changes 
over time. The PEDI‑CAT demonstrates excellent reliability, with test–retest intraclass correlation 
coefficients typically above 0.90 across domains, and strong internal consistency supported by Rasch 
modelling. Validity is well established, including good construct validity demonstrated through 
expected associations with functional classification levels (e.g., GMFCS), and discriminant validity 
showing clear differentiation across severity groups (16, 22). 
Secondary outcomes 
Secondary outcomes cover domains of physical performance, functional ability beyond mobility, 
participation, and health‑related quality of life: 

Physical performance tests 
Standardized physical performance tests will be conducted by trained test personnel using uniform 
protocols to ensure consistency across sites. Tests are selected based on their feasibility for children 
with motor impairments and their relevance to functional gains expected from Frame Running. The 
physical test battery comprises three validated and widely used performance measures, supplemented 
by a study‑specific Frame Running test developed to capture functional capacity in participants who 
have limited or no walking or standing ability: 
 6‑Minute Frame Running Test (6MFRT): 
An endurance test in which the child or young person covers as much distance as possible on 
a Frame Runner within six minutes. The test provides an indicator of aerobic capacity and 
functional endurance specifically during Frame Running (23, 24). 
 10‑Meter Frame Running Sprint Test (10MFRST): 
A newly developed short‑distance sprint test in which the child or young person covers 10 
meters as quickly as possible from a stationary start on a Frame Runner. The test is designed 
to evaluate functional components of speed, acceleration, and explosive mobility within 
frame‑based running movements. 
 1‑Minute Sit‑to‑Stand Test (1MSTS): 
A strength and endurance test in which the child or young person performs as many 
sit‑to‑stand repetitions as possible within one minute. The test evaluates lower‑limb power, 
muscular endurance, and functional strength relevant for daily activities (25, 26). 
 1‑Minute Walk Test (1MWT): 
A short endurance test measuring the distance a child or young person can walk in one minute. 
It offers a quick assessment of functional mobility and walking pace (27, 28). 
 
Functional ability (PEDI‑CAT secondary domains) 
Functional ability beyond mobility will be assessed using the Pediatric Evaluation of Disability 
Inventory – Computer Adaptive Test (PEDI‑CAT) Daily Activities, Social/Cognitive, and 
Responsibility domains. These domains assess self‑care and daily activities, social interaction and 
cognitive functioning, and independence in managing daily life tasks, respectively. 
Participation 

Participation will be assessed using the Children’s Assessment of Participation and Enjoyment / 
Preference for Activities of Children (CAPE-PAC). The instrument evaluate how children participate 
in everyday activities, including diversity, intensity, context, and preference (29). 
Health‑related quality of life 
Health‑related quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL), 
a validated pediatric patient‑reported outcome instrument covering physical, emotional, social, and 
school functioning (30). 
 
Explorative outcomes 
In addition to the primary and secondary outcomes, a few exploratory measures will be collected to 
provide supplementary insight into training intensity and psychosocial impact.  
 
Psychosocial impact 
The psychosocial impact of assistive devices is assessed using the Psychosocial Impact of Assistive 
Devices Scale (PIADS), which captures perceived competence, adaptability, and self‑esteem. PIADS 
is administered alongside the other questionnaires to explore broader psychosocial effects of 
participating in Frame Running and using the Frame Runner (31). 
Rating of Perceived Exertion—Pediatric Scale (RPE‑P) 
Perceived exertion will be assessed using a child-friendly visual version of BORG RPE (32) the 
Rating of Perceived Exertion—Pediatric Scale (RPE‑P) (33) immediately before and after the 
6‑Minute Frame Running Test. This measure provides a subjective indicator of exertion and 
perceived effort, supporting interpretation of physiological responses and individual variation in 
intensity tolerance. RPE‑P have demonstrated good validity in children and adolescents (33). 
 
Intervention Exposure and Fidelity Measures 

Training diary, trainer logs, and SENS accelerometer data are collected as intervention exposure and 
fidelity measures rather than outcomes. These measures provide essential information about training 
dose, adherence, and delivery quality, but are not included as study outcomes. 
Training diary (participant‑reported) 
Following each training session, participants (with assistance from parents if needed) will complete 
a training diary documenting: 
 date and duration of the session, 
 whether training occurred at the club or at home, 
 perceived intensity using the green/yellow/red intensity scale derived from the project’s 
training manual. 
The diary enables monitoring of adherence, training dose, and participant‑reported intensity during 
both the control and intervention periods. 
Training log (coach‑reported) 
After each training session, coaches complete a structured trainer log, which enables documentation 
of attendance, adherence to the training manual, training intensity, and any deviations or adverse 
events. These logs contribute to assessment of intervention fidelity, safety monitoring, and contextual 
interpretation of training exposure. 
Physical activity measurement 
Objective physical activity will be recorded using a SENS motion® (Copenhagen, Denmark) 
accelerometer. In addition, a heart‑rate monitor will be used during physical performance tests to 
provide complementary information on physiological intensity. Together, the accelerometer and 
heart‑rate data offer objective estimates of activity levels, movement patterns, and changes in habitual 
physical activity across study phases. 
 
Data collection procedures 
All physical performance tests are performed on‑site in the athletics club environment, scheduled in 
connection with regular training sessions to minimize participant burden. Test personnel involved in 
physical testing will receive standardized training to ensure consistency across sites.  

Questionnaire data are distributed digitally via secure mail (e‑Boks) and monitored for completeness 
at each assessment time point via REDCap® (Research Electronic Data Capture, Vanderbilt 
University, USA). The participant training diary is completed electronically via the myCAP® mobile 
application (REDCap, Vanderbilt University, USA), which sends notifications to the parent/guardian 
prompting registration of training frequency, duration, location, and perceived intensity. 
Coaches complete trainer logs after each session by scanning a QR code that provides direct access 
to a structured questionnaire in the SurveyXact platform (Ramboll, Denmark). 
Objective physical activity is recorded using a thigh‑worn - or alternatively shoe-worn - SENS 
motion® (Copenhagen, Denmark) accelerometer, fitted during test sessions and worn for three 
predefined two‑week periods:  
 the first two weeks of the control period (T0) 
 the last week of the control period and first week of intervention period (T1) 
 the last two week of the intervention period (T2) 
During physical performance tests, heart‑rate data are collected using arm‑worn heart‑rate monitor to 
complement the accelerometer data. Data are downloaded and checked for completeness upon return. 
Table 1 provides an overview of all study outcomes, including their domains, instruments, and 
assessment time points. 
 
Table 1. Overview of Outcome Measures 
Outcome type 
Outcome measure 
Domain 
Instrument / test 
Time points 
Primary 
Functional ability 
Mobility 
PEDI-CAT  
T0, T1, T2 
Secondary 
Physical 
performance 
Endurance / mobility 
capacity / speed 
6MFRT, 1MWT, 
1MSTS, 10MFRST 
T0, T1, T2 
Secondary 
Functional ability 
Daily activities, 
social/cognitive, 
participation 
PEDI-CAT 
T0, T1, T2 
Secondary 
Participation 
Activity diversity, intensity 
context 
CAPE/PAC 
T0, T1, T2 
Secondary 
Health-related 
quality of life 
Physical, emotional, social, 
school functioning 
PedsQL 
T0, T1, T2 
Exploratory 
Psychosocial 
impact 
Competence, adaptability, 
self-esteem 
PIADS 
T0, T1, T2 

Exploratory 
Perceived exertion 
Subjective intensity 
Rating of Perceived 
Exertion—Pediatric 
Scale (RPE‑P) 
T0, T1, T2 
Exploratory 
Long-term changes 
Participation, QoL, 
functional ability 
All questionnaire-based 
outcomes 
T3, T4 
 
Table 2 summarises the intervention exposure and fidelity measures collected to contextualise 
training dose and delivery. 
 
Table 2. Overview of Exposure and Fidelity Measures 
Measure type 
Variable 
Instrument 
Time points 
Participant-reported exposure 
Frequency, duration, location, 
perceived intensity, enjoyment 
Training Diary 
(myCAP® app, 
REDCap®) 
After each session 
Coach-reported fidelity 
Attendance, manual adherence, 
intensity, safety 
Trainer Log 
(SurveyXact) 
After each session 
Objective activity exposure 
Habitual physical activity, 
movement intensity, heart rate 
SENS motion® 
accelerometer + 
heart‑rate monitor 
T0, T1, T2 
 
Planned statistical analysis 
Descriptive statistics (means and standard deviations for continuous variables; frequencies and 
percentages for categorical variables) will be used to summarise participant characteristics at baseline. 
Between‑timepoint comparisons for descriptive purposes will be explored using paired t‑tests for 
continuous variables and chi‑square tests for categorical variables.  
Longitudinal changes across T0, T1 and T2 (between-periods change score - control period versus 
intervention period) will be analysed using a paired (subjects are their own controls) random-effects 
mixed linear models, enabling estimation of average change over time under the assumption of 
normally distributed residuals. Missing data will be handled using maximum likelihood estimation, 
which allows inclusion of participants with incomplete repeated‑measures data. Analyses will be 
undertaken both per protocol and according to the intention‑to‑treat principle. For this study, 
intention‑to‑treat means that participants with partial follow‑up or incomplete outcome data will 
remain included in the analysis through likelihood‑based approaches. A per‑protocol analysis will be 

conducted including only participants who achieve at least 75% adherence to the prescribed training 
dose across the intervention period. Adherence will be calculated based on completed training 
sessions (club‑based and home‑based) relative to the prescribed number of sessions. Participants 
below this adherence threshold will be excluded from the per‑protocol analysis but retained in the 
intention‑to‑treat analysis through likelihood‑based approaches. 
Long‑term questionnaire data at T3 and T4 will be analysed descriptively and explored using 
extended mixed models where appropriate. 
All statistical tests will use a significance level of p = 0.05 and 95% confidence intervals. Analyses 
will be performed using Stata 19 (StataCorp LP, College Station, TX, USA). 
Training diary data and trainer logs will be analysed descriptively to characterise training exposure, 
adherence, session intensity, and intervention fidelity. Continuous variables (e.g., session duration) 
will be summarised using means and standard deviations or medians and interquartile ranges, while 
categorical variables (e.g., location, attendance, manual adherence) will be summarised using 
frequencies and percentages. These exploratory data will support contextual interpretation of dose–
response patterns and fidelity across sites. 
Accelerometer data (SENS) and accompanying heart‑rate data are collected as exploratory outcome 
measures and will be analysed in a separate study; they are therefore not included in the present 
analysis plan. 
 
Ethical considerations and data management 
The study will follow the principals of the Declaration of Helsinki (34) and has been evaluated by the 
Regional Committee on Health Research Ethics (Region of Southern Denmark) (S-20232000 – 99) 
and Research Ethics Committee at the University of Southern Denmark (SDU-REC) (REC598), 
which has assessed it as not being subject to further notification/evaluation. The General Data 
Protection Regulation (GDPR) will be followed.  
Children and their parents/guardians will be provided oral and written information about the 
respective study, and informed parental consent and child assent will be obtained by the project 
coordinator. Written information will be developed in a child version and a parent version. 

A data management plan (DMP) has been developed, providing details on how data will be collected 
and managed throughout the project, as well as how they will be documented, stored, and archived 
after the project has been concluded.  
All study data, including the final study dataset, will be treated confidentially, and access will be 
restricted to the research team. When reporting findings, no data will be traceable to individual 
participants. 
Dissemination 
Dissemination plans include peer-review publication of study results in national and international 
journals for publication irrespective of the outcome. In addition, results will be presented at scientific 
and non-scientific meetings and conferences with all relevant key stakeholders.  
 
Discussion 
This study protocol presents a quasi‑experimental single‑arm evaluation of a structured Frame 
Running intervention for children and young people with physical disabilities. The study addresses a 
gap in current evidence, as research on functional and participatory outcomes of adaptive sports 
remains limited, particularly for children with significant mobility limitations. By combining 
quantitative outcomes with qualitative observations and interviews, the study aims to generate a 
nuanced understanding of how Frame Running may support functional ability, participation, and 
quality of life. 
The pragmatic nature of this design is central. Embedding the intervention within existing athletics 
clubs ensures ecological validity, supports feasibility, and mirrors how Frame Running is practiced 
in real‑world community settings. The two-phase structure - with a low‑intensity control period 
followed by a moderate‑to‑high intensity intervention - facilitates examination of change over time 
while balancing methodological rigor with ethical and practical considerations in this population. The 
rolling inclusion procedure further reduces the risks of seasonal bias. The study also benefits from a 
comprehensive outcome battery, long‑term follow‑ups (6 and 12 months), and detailed process 
measures capturing adherence, intensity, and fidelity. 
A key strength of this study is the integration of multiple data sources - physical tests, standardized 
questionnaires, training diaries, and trainer logs - allowing for a multidimensional evaluation of the 
intervention. The structured training manual and coach supervision support fidelity, while the 
inclusion of children and young people with varying levels of mobility increases generalizability. 

Also some limitations must be acknowledged. The lack of randomisation limits causal inference, and 
although the within‑subject design and repeated measurements reduce inter‑individual variability, 
residual confounding (e.g., maturation effects or unmeasured contextual factors) may persist. 
Reliance on self‑reported training diaries introduces potential recall bias, though notifications aim to 
enhance completeness. Variation across clubs and coaches may influence delivery despite the 
standardized manual. 
  
Despite these considerations, the study is expected to provide valuable evidence regarding the 
potential impacts, feasibility, and lived experiences associated with Frame Running. Findings may 
contribute to the development of scalable community‑based adaptive sport programs and inform 
clinical and municipal practices regarding physical activity for children with physical disabilities. 
 
Conclusion 
In conclusion, this study protocol presents a robust and methodologically well‑justified study 
designed to evaluate the benefits of a structured Frame Running intervention. The combination of 
quantitative and qualitative methods (embedded in this study but described elsewhere), long‑term 
follow‑up, and real‑world setting enhances the study’s potential to advance the evidence base for 
adaptive sports and to inform practice in paediatric rehabilitation, community sports clubs, and 
disability services. The findings are expected to contribute meaningful and actionable knowledge on 
how Frame Running may support functional ability, participation, and quality of life among children 
and young people with physical disabilities. 
 
 
 

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