Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000564550
Ethics application status
Approved
Date submitted
19/02/2024
Date registered
5/05/2024
Date last updated
22/09/2024
Date data sharing statement initially provided
5/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Constraint-Induced Movement Therapy Combined with Neuromuscular Electrical Stimulation on Upper Extremity Function in Chronic Stroke Survivors
Scientific title
Effect of Constraint-Induced Movement Therapy (CIMT) Combined with Neuromuscular Electrical Stimulation on Upper Extremity Function in Chronic Stroke Survivors in Comparison to CIMT alone and Conventional Therapy
Secondary ID [1] 311504 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Extremity Dysfunction in Chronic Stroke Survivors 332839 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329555 329555 0 0
Physiotherapy
Stroke 330047 330047 0 0
Haemorrhagic
Stroke 330048 330048 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants will be enrolled in either one of the three groups:
Group 1: Constraint-Induced Movement Therapy (CIMT) task practice using a number of repetitions of shaping practice (300 repetitions). The number of participants = 14 stroke patients.
Group 2: CIMT task practice using a number of repetitions of shaping practice (300 repetitions) combined with Neuromuscular Electrical Stimulation (NMES). The number of participants = 14 stroke patients.
Group 3: Control group that will receive conventional therapy treatment. The number of participants = 14 stroke patients.
All treatment protocols will be administered 3 times per week for 4 weeks.

Intervention 1: In the CIMT group, the shaping practice of CIMT will perform a number of repetitions of shaping practice in the following tasks: Picking up a cup from the table, taking it to the mouth, and putting it back; writing letters or drawing a circle; picking up an object (a pen or pencil) and transferring from left to right on a table; taking the hand from the lap to the head and sliding it from the front to the back; taking the hand to the nose; and putting and removing shoes. Each of these 6 tasks will be carried out 50 times, which totals 300 repetitions per session.
The number of participants = 14 stroke patients.

Intervention 2: In the CIMT + NMES group, the shaping practice of CIMT will perform functional tasks similar to the tasks carried out by the CIMT group. Besides that, the NMES will be combined with CIMT tasks. In the NMES, the stimulation will be conducted by the bio-feedback electrical stimulator. Subjects sit with their arms and hands resting at the sides and forearms pronated. The 2 stimulating electrodes shall be placed on the muscle belly of the extensor carpi radialis on the paretic side. The electrical stimulation treatments will be performed for 20 minutes per session.
The number of participants = 14 stroke patients.

The unaffected upper extremity will be constrained for 90% of the patient’s waking hours. In all cases, the constraint device will be used (a padded mitt or oven mitt) due to its low cost, ready availability, and easy-care requirements.

The activities of task practice will be completed by using the affected limb. The researcher and physiotherapists at NASAM will conduct the intervention sessions. The mode of administration will be by groups.

A blinded assessor will measure the intervention outcomes for all participants in the feasibility study and the RCT study. The feasibility of interventions will be assessed with regard to patients' acceptance and adherence and the occurrence of adverse effects.
1. Stroke survivor's acceptance will be collected during post-trial assessment with the question “What do you think about this therapy?”. Responses from the survivors will be categorized into positive and negative responses and analyzed descriptively.
2. Adherence rate will be reported in terms of percentages of practice (the number of sessions performed out of the total sessions required). The number of practice sessions performed will be obtained from the participants' logbooks.
3. The occurrence of adverse effects related to exercise such as muscle soreness, cramps, and muscle strain will be monitored (once every week) and during post-trial assessment.
Intervention code [1] 327953 0
Rehabilitation
Comparator / control treatment
The number of participants in the control group will be 14 stroke patients.
Participants in the control group will receive the usual care. Usual care is defined as conventional rehabilitation, which will be focused on neurodevelopmental techniques emphasizing functional task practice, when possible, passive and active movements, therapeutic positioning, strength, and range of motion, as well as weight bearing by the affected limb and fine motor dexterity activities.

The frequency and duration of sessions will be 60-minute sessions and will be administered 3 times per week for 4 weeks.

The researcher and physiotherapists at NASAM will conduct the intervention sessions. The mode of administration will be by groups.

A blinded assessor will measure the intervention outcomes for all participants in the feasibility study and the RCT study. The feasibility of interventions will be assessed with regard to patients' acceptance and adherence and the occurrence of adverse effects.
1. Stroke survivor's acceptance will be collected during post-trial assessment with the question “What do you think about this therapy?”. Responses from the survivors will be categorized into positive and negative responses and analyzed descriptively.
2. Adherence rate will be reported in terms of percentages of practice (the number of sessions performed out of the total sessions required). The number of practice sessions performed will be obtained from the participants' logbooks.
3. The occurrence of adverse effects related to exercise such as muscle soreness, cramps, and muscle strain will be monitored (once every week) and during post-trial assessment.
Control group
Active

Outcomes
Primary outcome [1] 337348 0
Perceived Motor Function
Timepoint [1] 337348 0
At baseline and the end of the intervention (4 weeks post-commencement of the intervention),
Primary outcome [2] 337349 0
Motor Impairment
Timepoint [2] 337349 0
At baseline and the end of the intervention (4 weeks post-commencement of the intervention),
Primary outcome [3] 337350 0
Motor Function
Timepoint [3] 337350 0
At baseline and the end of the intervention (4 weeks post-commencement of the intervention),
Secondary outcome [1] 431527 0
Upper Limb Self-efficacy
Timepoint [1] 431527 0
At baseline and the end of the intervention (4 weeks post-commencement of the intervention),

Eligibility
Key inclusion criteria
1. Stroke survivors (ischemic or hemorrhagic), last subacute stroke (4-6) months; and chronic stroke more than 6 months post-onset.
2. A score of greater than or equal to 3 on the upper arm item of the Motor Assessment Scale (MAS).
3. A score of greater than or equal to 26 on the Montreal Cognitive Assessment (MoCA).
4. A grade of less than or equal to 2 on the Modified Ashworth Scale for upper extremity and lower extremity.
5. No history of upper extremity injuries.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A greater than or equal to 2 of sensory loss on the sensory item of the National Institutes of Health Stroke Scale (NIHSS).
2. Patients with pacemakers or tumors.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants will be recruited from the National Stroke Association Of Malaysia (NASAM). Three NASAM centers will be randomly allocated to manage either one of the three groups, namely, the CIMT group, the CIMT + NMES group, or the control group. The randomization process for the centres will be done using a'sealed opaque envelope’ by health personnel blinded to the study. Once done, all eligible patients at the centre will be in the decided group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study will utilize a clustered Randomized controlled trial research design. The participants will be recruited from the National Stroke Association Of Malaysia (NASAM). Three NASAM centres will be randomly allocated to manage either one of the three groups, namely, the CIMT group, the CIMT + NMES group, or the control group. The randomization process for the centres will be done using a ‘sealed opaque envelope’ by health personnel blinded to the study. Once done, all eligible patients at the centre will be in the decided group.
The sequence generation will be done by simple randomization using procedures like coin-tossing and dice-rolling.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
G Power software version 3.0.10 was used to estimate the required sample size for this study. This study used mixed model analysis of variance (ANOVA) to analyze the time, group, and interaction effects of the interventions. Therefore, the F-test (ANOVA repeated measure, within-between interactions) was chosen. The study power was set at 80%, and the alpha value was set at 0.05. Based on those parameters and the effect size of primary outcomes, a minimum sample size of 42 subjects is required (14 participants in each group).

All data will be entered into IBM SPSS version 23.0. The Intention-to-treat (ITT) method will be used; all the participants recruited at baseline will be included in the outcome analysis. Using ITT, missing data will be replaced with the last observation carried forward. The socio-demographic and health profiles of the participants will be analyzed descriptively and reported as frequencies (percentages), mean (standard deviation), or median (inter-quartile range). Effects of the interventions and comparisons between and within groups will be analyzed using Two-way mixed ANOVA and reported as main time, group, and time-group interaction effects for each intervention outcome. The level of significance will be set at P < 0.05 for all results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/07/2024
Actual
29/07/2024
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
42
Accrual to date
42
Final
Recruitment outside Australia
Country [1] 26142 0
Malaysia
State/province [1] 26142 0

Funding & Sponsors
Funding source category [1] 315794 0
University
Name [1] 315794 0
Universiti Kebangsaan Malaysia (UKM)
Country [1] 315794 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia (UKM)
Address
Country
Malaysia
Secondary sponsor category [1] 317929 0
None
Name [1] 317929 0
Address [1] 317929 0
Country [1] 317929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314652 0
Research Ethics Committee Universiti Kebangsaan Malaysia (RECUKM )
Ethics committee address [1] 314652 0
Ethics committee country [1] 314652 0
Malaysia
Date submitted for ethics approval [1] 314652 0
07/08/2023
Approval date [1] 314652 0
17/11/2023
Ethics approval number [1] 314652 0
UKM PPI/111/8/JEP-2023-596

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132290 0
A/Prof Nor Azlin Mohd Nordin
Address 132290 0
Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 132290 0
Malaysia
Phone 132290 0
+60193594418
Fax 132290 0
Email 132290 0
[email protected]
Contact person for public queries
Name 132291 0
Mahmoud M. Dboba
Address 132291 0
Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 132291 0
Malaysia
Phone 132291 0
+601161940198
Fax 132291 0
Email 132291 0
[email protected]
Contact person for scientific queries
Name 132292 0
Mahmoud M. Dboba
Address 132292 0
Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 132292 0
Malaysia
Phone 132292 0
+601161940198
Fax 132292 0
Email 132292 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.