Stroke Gait RehabilitationNCT06878677
Individualized Exercise Prescription With a Data-driven Approach in Individuals With Stroke
A study testing Data-driven exercise and Standardized exercises in people with Stroke Gait Rehabilitation and Stroke Patients, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke Gait Rehabilitation, Stroke Patients, Stroke
- What is being tested?
- Data-driven exercise and Standardized exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- any existing medical condition such as uncontrolled hypertension that hindered training or assessment;
- unable to offer consent due to impaired cognitive function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
the Hong Kong Polytechnic University
Hksar
Assistant Professor Dr. Patrick Kwong, 852 3400 3958, wai-hang.kwong@polyu.edu.hk
About this study
Official title: Individualized Exercise Prescription With a Data-driven Approach in Individuals With Stroke - A Feasible Study
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?
Read more
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).
Read the 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
- Being tested
- Data-driven exercise, Standardized exercises
- Keywords
- stroke, lower extremities, gait, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data-driven exerciseOther
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.
Standardized exercisesBehavioural
The participants will perform dose match standardised exericse program.
| Study group | Role | What they receive |
|---|---|---|
| Data-driven exercise group | Experimental | 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. Receives: Other: Data-driven exercise |
| Standarzied exercise group | Placebo comparator | 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. Receives: Behavioral: Standardized exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait kinematics
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.
Measured: At baseline and 6 weeks post-intervention
Secondary outcomes (8)
Electromyography (EMG) signals in Maximum Voluntary Contraction (MVC) and muscle activation during gait
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.
Measured: At baseline and 6 weeks post-intervention
Fugl-Meyer assessment (FMA-LE)
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.
Measured: At baseline and 6 weeks post-intervention
Berg Balance Scale (BBS)
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.
Measured: At baseline and 6 weeks post-intervention
Subjective Index of physical and Social Outcome (SIPSO)
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.
Measured: At baseline and 6 weeks post-intervention
Short Physical Performance Battery (SPPB)
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.
Measured: At baseline and 6 weeks post-intervention
Trunk Impairment Scale (TIS)
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.
Measured: At baseline and 6 weeks post-intervention
Ability to Perform Locomotion Activities (ABILOCO)
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.
Measured: At baseline and 6 weeks post-intervention
Timed Up and Go (TUG) test
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.
Measured: At baseline and 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Gait RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Patrick Kwong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878677
- Sponsor's protocol ID
- HSEARS20240216001
- Status last verified
- Sep 2025
- First submitted
- 3 Mar 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Exercise Prescription With a Data-driven Approach in Individuals With Stroke - A Feasible Study
- ClinicalTrials.gov ID
- NCT06878677
- Acronym / sponsor ID
- HSEARS20240216001
- Conditions
- Stroke Gait Rehabilitation, Stroke Patients, Stroke
- Keywords
- stroke, lower extremities, gait, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Two arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Data-driven exercise group | Experimental | Other: Data-driven exerciseBased 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. |
| Standarzied exercise group | Placebo comparator | Behavioral: Standardized exercisesParticipants 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- any existing medical condition such as uncontrolled hypertension that hindered training or assessment;
- unable to offer consent due to impaired cognitive function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data-driven exerciseThe 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. | Other | Data-driven exercise group |
| Standardized exercisesThe participants will perform dose match standardised exericse program. | Behavioural | Standarzied exercise group |
Primary outcome
Gait kinematics
Time frame: 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.
8 secondary outcomes
Electromyography (EMG) signals in Maximum Voluntary Contraction (MVC) and muscle activation during gait
Time frame: At baseline and 6 weeks post-intervention
Fugl-Meyer assessment (FMA-LE)
Time frame: At baseline and 6 weeks post-intervention
Berg Balance Scale (BBS)
Time frame: At baseline and 6 weeks post-intervention
Subjective Index of physical and Social Outcome (SIPSO)
Time frame: At baseline and 6 weeks post-intervention
Short Physical Performance Battery (SPPB)
Time frame: At baseline and 6 weeks post-intervention
Trunk Impairment Scale (TIS)
Time frame: At baseline and 6 weeks post-intervention
Ability to Perform Locomotion Activities (ABILOCO)
Time frame: At baseline and 6 weeks post-intervention
Timed Up and Go (TUG) test
Time frame: At baseline and 6 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data-driven exercise and Standardized exercises in people with Stroke Gait Rehabilitation and Stroke Patients, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assistant Professor wai-hang Kwong, PhD (85234003958, wai-hang.kwong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait kinematics (time frame: At baseline and 6 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.