Clinical trial NCT06878677: Individualized Exercise Prescription with a Data-driven Approach in Individuals with Stroke
Official title: Individualized Exercise Prescription with a Data-driven Approach in Individuals with Stroke - a Feasible Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Gait Rehabilitation
Stroke Patients
Stroke
Keywords: stroke
lower extremities
gait
rehabilitation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 52
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate if the exercised via data-driven approach is effective in enhance the gait pattern in people with stroke. It will reduce burdun of patient consultations for clinicians in reality.The main questions it aims to answer are:

Does individualized exercise training programmes via data-driven approach could improve gait patterns in individuals with chronic stroke? Does individualized exercise training programmes via data-driven approach could improve improve motor recovery, motor functions (including gait speed and balance performance), and community integration in individuals with chronic stroke?

Participants will:

Undergo 12 supervised-exercise (training sessions (60 minutes, two times a week, for six weeks), Participants will receive a data-driven exercise prescription or conventional exercise prescription which consists of 5 different exercises.

They will be assessed on Baseline assessment before training (A0); after six sessions (A1); after 12 sessions (A2); and three months after training (A3).

Detailed description: Based on the results of the gait patterns and Electromyography (EMG) analysis, the principal investigator (PI) will design appropriate exercises that target the specific gait impairment at a specific time period during the gait cycle. Exercises will utilize various modalities that are commonly used in clinical practice, including TheraBand, gym equipment, free weight. The training may target single-joint movement or targeting a movement pattern that involves multiple joint holistically. A body harness system will be used to protect the participant during the exercise training. The participant will be supervised by a research assistant who has rich experience in conducting exercise training on people with disability. Below are potential exercises that will be prescribed to the participant based on their impairment revealed by the analyses. eg. Lack of hip flexion during swing phase: Open kinetic chain strengthing exercise for hip flexor in a concentric manner...

Eligibility criteria: Inclusion Criteria:

* between 45 and 75 years old;
* have received a diagnosis of stroke more than six months earlier;
* able to walk 10 m independently;
* able to score at least 6 of 10 on the Abbreviated Mental Test;
* able to follow instructions and give informed consent.

Exclusion Criteria:

* any existing medical condition such as uncontrolled hypertension that hindered training or assessment;
* unable to offer consent due to impaired cognitive function.

Primary outcomes:
measure: Gait kinematics
timeFrame: At baseline and 6 weeks post-intervention
Secondary outcomes:
measure: Electromyography (EMG) signals in Maximum Voluntary Contraction (MVC) and muscle activation during gait
timeFrame: At baseline and 6 weeks post-intervention
measure: Fugl-Meyer assessment (FMA-LE)
timeFrame: At baseline and 6 weeks post-intervention
measure: Berg Balance Scale (BBS)
timeFrame: At baseline and 6 weeks post-intervention
measure: Subjective Index of physical and Social Outcome (SIPSO)
timeFrame: At baseline and 6 weeks post-intervention
measure: Short Physical Performance Battery (SPPB)
timeFrame: At baseline and 6 weeks post-intervention
measure: Trunk Impairment Scale (TIS)
timeFrame: At baseline and 6 weeks post-intervention
measure: Ability to Perform Locomotion Activities (ABILOCO)
timeFrame: At baseline and 6 weeks post-intervention
measure: Timed Up and Go (TUG) test
timeFrame: At baseline and 6 weeks post-intervention
Other outcomes:
Locations:
city: Hksar
country: Hong Kong
facility: the Hong Kong Polytechnic University
Study officials:
References: