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

NCT06878677 | Recruiting

• 1 other identifier: HSEARS20240216001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke Gait Rehabilitation; Stroke Patients; Stroke

Keywords

stroke; lower extremities; gait; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and 6 weeks post-intervention

Secondary Outcomes (8)

• Electromyography (EMG) signals in Maximum Voluntary Contraction (MVC) and muscle activation during gait

  At baseline and 6 weeks post-intervention

• Fugl-Meyer assessment (FMA-LE)

  At baseline and 6 weeks post-intervention

• Berg Balance Scale (BBS)

  At baseline and 6 weeks post-intervention

• Subjective Index of physical and Social Outcome (SIPSO)

  At baseline and 6 weeks post-intervention

• Short Physical Performance Battery (SPPB)

  At baseline and 6 weeks post-intervention

Study Arms (2)

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.

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.

Behavioral: Standardized exercises

Interventions

Data-driven exercise 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.

Data-driven exercise group

Standardized exercises BEHAVIORAL

The participants will perform dose match standardised exericse program.

Standarzied exercise group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

the Hong Kong Polytechnic University

Hksar, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Assistant Professor wai-hang Kwong, PhD

CONTACT

85234003958; wai-hang.kwong@polyu.edu.hk

Jiaqi Li, Master

CONTACT

85293694464; jiaqiqi.li@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two arm randomized controlled trial

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 17, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)