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

NCT ID: NCT06878677

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-10-31

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...

Conditions

Stroke Gait Rehabilitation; Stroke Patients; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Data-driven exercise group

Based on the results of the gait patterns, the 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.

Group Type: EXPERIMENTAL

Data-driven exercise

Intervention Type: OTHER

The result from the Statistical Parametric Mapping 1D (SPM1D) analysis will be used to identify the magnitude of deviation from normal gait patterns in reference to healthy subjects for each lower limb joint. Thereby, the targeted action and joint position can be identified. Training will focus on the specific movement where the "steepest gradients" are observed.

The targeted exercises will be selected based on the five largest deviations observed during the swing or stance phase. Open-chain exercises will be applied to address deviations in the swing phase, while closed-chain exercises will be applied to address deviation in the stance phase. Each exercise will be performed for approximately 80-100 repetitions, with a total duration of 10 minutes per exercise, including rest periods.

Standarzied exercise group

Participants in the standard exercise group will undergo a standardised exercise programme consisting of five lower-limb exercises commonly employed in clinical settings and prescribed to patients as home exercises. They include (1) stepping up and down to strengthen the muscles of both legs and to improve control in shifting the center of gravity; (2) heel-raising exercises on an inclined wedge to strengthen both ankle plantarflexors; (3) assuming a semi-squatting position to improve lower-limb muscle endurance and proprioception in the knees and ankles; (4) standing on a dura disk to improve dynamic standing balance; (5) walking across obstacles to enhance anticipatory postural control.

Group Type: PLACEBO_COMPARATOR

Standardized exercises

Intervention Type: BEHAVIORAL

The participants will perform dose match standardised exericse program.

Interventions

Data-driven exercise

The result from the Statistical Parametric Mapping 1D (SPM1D) analysis will be used to identify the magnitude of deviation from normal gait patterns in reference to healthy subjects for each lower limb joint. Thereby, the targeted action and joint position can be identified. Training will focus on the specific movement where the "steepest gradients" are observed.

The targeted exercises will be selected based on the five largest deviations observed during the swing or stance phase. Open-chain exercises will be applied to address deviations in the swing phase, while closed-chain exercises will be applied to address deviation in the stance phase. Each exercise will be performed for approximately 80-100 repetitions, with a total duration of 10 minutes per exercise, including rest periods.

Intervention Type: OTHER

Standardized exercises

The participants will perform dose match standardised exericse program.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Patrick Kwong

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Hong Kong Polytechnic University

Hksar, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Assistant Professor wai-hang Kwong, PhD

Role: CONTACT

wai-hang.kwong@polyu.edu.hk

85234003958

Jiaqi Li, Master

Role: CONTACT

jiaqiqi.li@connect.polyu.hk

85293694464

Facility Contacts

Assistant Professor Dr. Patrick Kwong

Role: primary

wai-hang.kwong@polyu.edu.hk

852 3400 3958

Other Identifiers

HSEARS20240216001

Identifier Type: -

Identifier Source: org_study_id