Clinical trial NCT05412485: Gait Improvement After Increased Frequency of Robot-assisted Gait Training in Cerebral Palsy Children
Official title: Does Increased Frequency of Robot-assisted Gait Training Improve Gait Functions and Quality of Gait in Children With Cerebral Palsy: A Single Blinded, Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy Spastic Diplegia
Keywords: Randomized pilot study
Cerebral palsy
Robotic assisted gait training
gait function
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective single blinded parallet-group, randomized clinical trial would be conducted.
Primary purpose: TREATMENT

Brief summary: Robot-assisted gait training (RAGT) can provide a longer training duration with a higher repetition of stepping while maintaining a stable pattern of movement. However, the existing evidence of its effectiveness is not clear. The aim of this study is to investigate the feasibility and the effect of increased frequency (4 times per week) of RAGT compared to the most common frequency (2 times per week). we hypothesize that increased frequency of RAGT will result in greater improvements on the gait functions. This research will investigate the effect of increased frequency on robotic assisted gait training (RAGT) in a frequency of 4 times per a week, and will compare the effect of robotic assisted gait training (RAGT) with increased frequency and with usual frequency (2 times per a week) in regards with gait functional parameters such as balance, speed, endurance, and quality of gait among cerebral palsy (CP) children's.

Detailed description: Cerebral palsy (CP) is defined as a group of disorders that affect mobility and posture with heterogeneous impairments such as muscle tone alternation, reduced selective motor control, joint contracture, postural control impairment and weakness of muscles. Independent walking is a priority goal for a lot of parents and children with CP.

RAGT has been considered as a revolutionary technology for gait enhancement. Lokomat, as one of RAGT devices, provides the intensive gait training with a number of repetitions of stepping while it preserves consistent pattern of movement. Lokomat with additional virtual reality games adds fun and challenge and enhances the involvement and motivation throughout the whole session. We will use Lokomat for RAGT for 6 weeks phase for both treatement and control groups. Only difference between groups is the frequency: 4 times a week for treatment group and 2 times a week for intervention group.

General gait and standing function will be measured by Gross motor function measure dimension E and D. Speed, endurance, balance, and quality of gait would be measured by 10 meter walk test, 6 minutes walk test, pediatric balance scale, and Edinburgh visual gait score. To our knowledge no previous studies investigated the effect of the increased frequency in RAGT with lokomat on improving gait speed, endurance, balance and quality in children with CP.

Eligibility criteria: Inclusion Criteria:

* children with spastic diplegia; being able to walk independently with or without using walking aids on at least 10 meters; classified as level Ι, II and ΙΙΙ in the gross motor function classification system (GMFCS).
* Children who can follow instructions of gross motor function measure (GMFM) testing and able to express discomfort and pain by verbal or nonverbal signs, having required range for lokomat (hip and knee flexion contracture ≤10°, knee valgus ≤40°, femur length ≥ 23 cm).

Exclusion Criteria:

* If they received botulinum toxin injections or underwent surgical intervention at least a year before the 6-week of the intervention or participated in another Lokomat training regime within the last 3 months.
* If they have: (a) fixed contractures and/or with bone instability; (b) seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months); (c) baclofen infusion pumps in situ, open skin lesions and vascular disorder of lower extremities.

Primary outcomes:
measure: The change in Gross motor function measure - Dimension E (GMFM E) between pre-treatment and post-treatment
timeFrame: will be measured at two intervals; pre-treatment and immediately after treatment
measure: The change in Pediatric balance scale (PBS) between pre-treatment and post-treatment
timeFrame: will be measured at two intervals; pre-treatment and immediately after treatment
measure: The change in Six minutes' walk test (6MWT) between pre-treatment and post-treatment
timeFrame: will be measured at two intervals; pre-treatment and immediately after treatment
measure: The change in Ten meter walk test (10MWT) between pre-treatment and post-treatment
timeFrame: will be measured at two intervals; pre-treatment and immediately after treatment
measure: The change in Edinburg visual gait score (EVGS) between pre-treatment and post-treatment
timeFrame: will be measured at two intervals; pre-treatment and immediately after treatment
Secondary outcomes:
measure: The change in Gross motor function measure - Dimension D (GMFM D) between pre-treatment and post-treatment
timeFrame: will be measured at two intervals; pre-treatment and immediately after treatment
Other outcomes:
Locations:
city: University city
country: United Arab Emirates
facility: University of Sharjah
state: Sharjah
Study officials:
affiliation: University of Sharjah
name: Meeyoung Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ammann-Reiffer C, Bastiaenen CH, Meyer-Heim AD, van Hedel HJ. Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT). BMC Pediatr. 2017 Mar 2;17(1):64. doi: 10.1186/s12887-017-0815-y.
citation: Aurich-Schuler T, Warken B, Graser JV, Ulrich T, Borggraefe I, Heinen F, Meyer-Heim A, van Hedel HJ, Schroeder AS. Practical Recommendations for Robot-Assisted Treadmill Therapy (Lokomat) in Children with Cerebral Palsy: Indications, Goal Setting, and Clinical Implementation within the WHO-ICF Framework. Neuropediatrics. 2015 Aug;46(4):248-60. doi: 10.1055/s-0035-1550150. Epub 2015 May 26.
citation: Hilderley AJ, Fehlings D, Lee GW, Wright FV. Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Springerplus. 2016 Oct 28;5(1):1886. doi: 10.1186/s40064-016-3535-0. eCollection 2016.
citation: Jin LH, Yang SS, Choi JY, Sohn MK. The Effect of Robot-Assisted Gait Training on Locomotor Function and Functional Capability for Daily Activities in Children with Cerebral Palsy: A Single-Blinded, Randomized Cross-Over Trial. Brain Sci. 2020 Oct 30;10(11):801. doi: 10.3390/brainsci10110801.
citation: Lefmann S, Russo R, Hillier S. The effectiveness of robotic-assisted gait training for paediatric gait disorders: systematic review. J Neuroeng Rehabil. 2017 Jan 5;14(1):1. doi: 10.1186/s12984-016-0214-x.