Individualized Exercise Prescription with a Data-driven Approach in Individuals with Stroke

Not Applicable

Recruiting

• Conditions: Stroke Gait Rehabilitation; Stroke Patients; Stroke

• Registration Number: NCT06878677
• Lead Sponsor: The Hong Kong Polytechnic University

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...

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Study Start: 2025-04-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait kinematics	At baseline and 6 weeks post-intervention	Seventeen wearable sensors (Inertial Measurement Units, IMUs) were attached to the participants' bodies in accordance with the Xsens user manual to collect kinematic data. The extracted data included the pelvis tilt angle (°), oblique angle (°), and rotation angle (°); hip flexion angle (°) and abduction angle (°); knee bending angle (°); as well as ankle flexion angle (°) and abduction angle (°), which were used for further analysis. These data were converted into standardized gait cycles (101 time points) for statistical parametric mapping (SPM1D) analysis, and the deviation time from the normal reference was compared to determine whether there were changes in deviation timing before and after the treatment.

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer assessment (FMA-LE)	At baseline and 6 weeks post-intervention	The lower extremity motor subscale of the Fugl-Meyer assessment (FMA-LE) was used to measure the level of lower extremity motor recovery after stroke. Quality of reflexes, coordination and voluntary movements of the paretic leg was assessed using a 0-to-34-point scale. Higher FMA-LE score indicated a better level of motor recovery.
Berg Balance Scale (BBS)	At baseline and 6 weeks post-intervention	Berg Balance Scale (BBS) was adopted to measure functional balance performance. The scale consists of 14 items, each rating a participant's ability to maintain stability in a specified functional task on a 5 point (0-4) scale. The maximal score of BBS is 56 and minimum is 0, with a higher score indicating better balance performance.
Subjective Index of physical and Social Outcome (SIPSO)	At baseline and 6 weeks post-intervention	The Chinese version of the subjective Index of physical and Social Outcome (SIPSO) questionnaire assesses the extent to which individuals with disabilities are able to function physically and socially to their own satisfaction. It is a 5 point (0-4) scale, the maximal score of SIPSO is 40 and minimum score is 0, with a higher score indicating better physical and social integration.
Short Physical Performance Battery (SPPB)	At baseline and 6 weeks post-intervention	The Short Physical Performance Battery (SPPB) is a tool used to assess lower extremity function and physical performance in older adults. It includes three components: Balance Tests: Measures ability to maintain balance in different stances. Gait Speed: Assesses walking speed over a short distance. Chair Stand Test: Evaluates leg strength by timing how quickly one can stand from a seated position multiple times.; The maximum score is 12 and the minimum score is 0, a higher score indicates better physical performance and functional ability.
Electromyography (EMG) signals in Maximum Voluntary Contraction (MVC) and muscle activation during gait	At baseline and 6 weeks post-intervention	Twelve Electromyography (EMG) sensors were placed on the left and right sides of the gluteus maximus, gluteus medius, quadriceps, hamstrings, tibialis anterior, and gastrocnemius muscles to measure Maximum Voluntary Contraction (MVC). In addition, the timing of each muscle activiation during gait cycle will be extracted to compared before and after training. This includes identifying the onset (activation start) and offset (activation end) of each muscle relative to specific phases of the gait cycle, such as the stance and swing phases.
Trunk Impairment Scale (TIS)	At baseline and 6 weeks post-intervention	The Trunk Impairment Scale (TIS) is an assessment tool used to evaluate trunk control and stability. It is primarily used for individuals with neurological conditions, such as stroke. The scale measures: Static Sitting Balance: Ability to maintain a stable sitting position. Dynamic Sitting Balance: Ability to maintain balance while moving. Coordination: Assesses coordinated trunk movements. It has a maximum score of 23 and minimum score of 0. The higher the score, the better the trunk control, stability, and coordination.
Ability to Perform Locomotion Activities (ABILOCO)	At baseline and 6 weeks post-intervention	ABILOCO is a questionnaire designed to assess locomotion and daily-life ability in individuals. It evaluates a person's capacity to perform various mobility tasks, ranging from simple to complex. The ABILOCO scale typically ranges from a minimum score of 0 to a maximum score of 59, where higher scores indicate better locomotion ability and greater independence in performing mobility tasks.
Timed Up and Go (TUG) test	At baseline and 6 weeks post-intervention	The Timed Up and Go (TUG) test was used to assess functional mobility, balance, and fall risk. Participants were instructed to stand up from a standard chair (45cm-height), walk a distance of 3 meters, turn around, walk back to the chair, and sit down. The total time taken to complete the task was recorded in seconds using a stopwatch. A shorter completion time indicates better functional mobility, while longer times may reflect impaired mobility or increased fall risk.

Trial Locations

Locations (1)

the Hong Kong Polytechnic University; 🇭🇰 Hksar, Hong Kong