Individualized Exercise Prescription With a Data-driven Approach in Individuals With Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorThe Hong Kong Polytechnic University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
any existing medical condition such as uncontrolled hypertension that hindered training or assessment;
unable to offer consent due to impaired cognitive function.
Trial design
Design model
Parallel
Treatments tested in this trial
Data-driven exercise
Other interventionThe 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 exercises
BehavioralThe participants will perform dose match standardised exericse program.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Data-driven exercise groupExperimental treatment 1 intervention
Group B: Standarzied exercise groupPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
At baseline and 6 weeks post-interventionSecondary outcomes
1
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.
Time frame
At baseline and 6 weeks post-intervention2
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.
Time frame
At baseline and 6 weeks post-intervention3
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.
Time frame
At baseline and 6 weeks post-intervention4
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.
Time frame
At baseline and 6 weeks post-interventionLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
the Hong Kong Polytechnic UniversityRecruiting Hksar
Hong Kong
Hong KongSponsors and contacts
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Source ClinicalTrials.gov