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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Stroke; Stroke Patients; Stroke Gait Rehabilitation

Treatments: Other: Data-driven exercise; Behavioral: Standardized exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06878677

HSEARS20240216001

Details and patient eligibility

About

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).

Full 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...

Enrollment: 52 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Data-driven exercise group

Experimental group

Description:

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.

Treatment:

Other: Data-driven exercise

Standarzied exercise group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Standardized exercises