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Recruiting NCT06878677

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

No phase Interventional Stroke Gait Rehabilitation Stroke Patients Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data-driven exercise, Standardized exercises.
Who it may be relevant to
Registry conditions: Stroke Gait Rehabilitation, Stroke Patients, Stroke. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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...

Interventions

  • Other 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 ex
  • Behavioral Standardized exercises
    The participants will perform dose match standardised exericse program.

Primary outcome measures

  • Gait kinematics [Time frame: At baseline and 6 weeks post-intervention]
Secondary outcome measures (8)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • the Hong Kong Polytechnic University — Hksar

Identifiers

NCT: NCT06878677 · HSEARS20240216001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗