Effects of Home-based CIMT and Clinic-based CIM on Stroke

Effects of Repetition Home-based Constraint Induced Movement Therapy (CIMT) Compared With Repetition Clinic-based CIMT on Outcomes Post Stroke: A Randomized Controlled Trial

Constraint induced movement therapy (CIMT) is based on the theoretical basis that constraining the unaffected limb following injury of the brain such as stroke can help overcome learned non-use. It comprises of constraint of the unaffected limb, massed tasks practice with the affected limb and a behavioral contract known as the transfer package whereby use of the affected limb is extended to the real-world situations. home-based rehabilitation is likely to be cost-effective, and it may reduce cost for patients in terms of hospital charges and transport fares. However, one of the major problems with the existing home-based CIMT protocols is that, they used number of hours spent carrying out tasks practice as the measure of intensity of practice, and it has been argued that, such method is not clear and it does not reflect the correct intensity of practice.

Study Overview

• Status: Recruiting
• Conditions: Motor Function
• Intervention / Treatment: Device: Home-based CIMT; Device: Clinic-based CIMT; Device: Control

Detailed Description

The aim of this study is to determine the effects of home-based CIMT compared with clinic-based CIMT that use number of repetition of tasks practice on motor impairment, motor function, quantity and quality of use of the limb in everyday life, community integration, stroke self-efficacy and quality of life. Constraint induced movement therapy (CIMT) can be administered either at home or in the clinic. The home-based CIMT is used to make CIMT easier for the patients

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shamay NG, PhD; Phone Number: +852 2766-4889; Email: shamay.ng@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Hong Kong Polytechnic University
    • Contact: Shamay Ng, PhD; Phone Number: 27664889; Email: Shamay.Ng@polyu.edu.hk
    • Principal Investigator: Shamay SM Ng, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have stroke 1-2 years before
• moderate disability
• a score of 1 to 3 on the motor arm item of the National Institutes of Health Stroke Scale (NIHSS)
• a score of 3 or more on the upper arm item of the Motor Assessment Scale (MAS)
• no significant cognitive impairment (a score of ≥24 points on Minimental state examination)

Exclusion Criteria:

• patients with re-stroke
• serious orthopaedic conditions such joint contracture, osteoarthritis and burns that will interfere with carrying out CIMT
• who are receiving rehabilitation at the time of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based CIMT; Participants and their families will be required to attend clinic to practice 3 times (Monday, Wednesday and Friday) during the first week, 2 times (Monday and Friday) during the second week and once (Monday) during the 3rd week under the supervision of a trained research assistant. They will be allowed to practice exclusively at home during the 4th week under the supervision of their family members.	Device: Home-based CIMT; Participants and their families will be required to attend clinic to practice 3 times (Monday, Wednesday and Friday) during the first week, 2 times (Monday and Friday) during the second week and once (Monday) during the 3rd week under the supervision of a trained research assistant. They will be allowed to practice exclusively at home during the 4th week under the supervision of their family members.
Experimental: Clinic-based CIMT; Participants in both groups will perform 5 tasks with the affected upper limb, each 100 times, making it 500 repetitions in total within a duration of 2 hours every day, five days a week for 4 weeks at home and in the clinic respectively. Details of the tasks to be performed are presented in table 1. We chose 2 hours because, patients with stroke can perform about 300 repetitions of tasks practice within one hour (Birkinmeier et al., 2014). Similarly, we chose 500 repetitions because the number of repetitions of tasks practice required for motor recovery ranges between 300 and 600 repetitions per day	Device: Clinic-based CIMT; Participants in both groups will perform 5 tasks with the affected upper limb, each 100 times, making it 500 repetitions in total within a duration of 2 hours every day, five days a week for 4 weeks at home and in the clinic respectively. Details of the tasks to be performed are presented in table 1. We chose 2 hours because, patients with stroke can perform about 300 repetitions of tasks practice within one hour. Similarly, we chose 500 repetitions because the number of repetitions of tasks practice required for motor recovery ranges between 300 and 600 repetitions per day
Placebo Comparator: Control; Participants will attend 45 minutes health talk provided by a research assistant twice in a week (Mondays and Fridays) in the clinic for 4 weeks. They will receive each talk in either a group of 3 or 5 patients. Similar control intervention was used in previous study	Device: Control; Participants will attend 45 minutes health talk provided by a research assistant twice in a week (Mondays and Fridays) in the clinic for 4 weeks. They will receive each talk in either a group of 3 or 5 patients. Similar control intervention was used in previous study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
upper limb Fugl Meyer motor assessment	valid and reliable instrument that assesses motor impairment following stroke. Items in the instrument are scored on a scale between 0 and 2, with a score 0 indicating cannot perform, a score of 1 indicating performs partially, and a score of 2 indicating performs fully. Scores obtained from the instrument can range from 0 to 66, with higher scores denoting higher ability.	at baseline
upper limb Fugl Meyer motor assessment	valid and reliable instrument that assesses motor impairment following stroke . Items in the instrument are scored on a scale between 0 and 2, with a score 0 indicating cannot perform, a score of 1 indicating performs partially, and a score of 2 indicating performs fully. Scores obtained from the instrument can range from 0 to 66, with higher scores denoting higher ability.	2 weeks
upper limb Fugl Meyer motor assessment	valid and reliable instrument that assesses motor impairment following stroke. Items in the instrument are scored on a scale between 0 and 2, with a score 0 indicating cannot perform, a score of 1 indicating performs partially, and a score of 2 indicating performs fully. Scores obtained from the instrument can range from 0 to 66, with higher scores denoting higher ability.	4 weeks
upper limb Fugl Meyer motor assessment	valid and reliable instrument that assesses motor impairment following stroke . Items in the instrument are scored on a scale between 0 and 2, with a score 0 indicating cannot perform, a score of 1 indicating performs partially, and a score of 2 indicating performs fully. Scores obtained from the instrument can range from 0 to 66, with higher scores denoting higher ability.	3 months follow up
Wolf motor function test (WMFT)	valid and reliable tool comprising of 17 items that assess motor function of the upper limb following stroke. Each of the items is rated on a scale of zero to 5, with higher scores denoting higher motor function. Similarly, the MAL is a valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.	at baseline
Wolf motor function test (WMFT)	valid and reliable tool comprising of 17 items that assess motor function of the upper limb following stroke. Each of the items is rated on a scale of zero to 5, with higher scores denoting higher motor function. Similarly, the MAL is a valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.	2 weeks
Wolf motor function test (WMFT)	valid and reliable tool comprising of 17 items that assess motor function of the upper limb following stroke. Each of the items is rated on a scale of zero to 5, with higher scores denoting higher motor function. Similarly, the MAL is a valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.	4 weeks
Wolf motor function test (WMFT)	valid and reliable tool comprising of 17 items that assess motor function of the upper limb following stroke. Each of the items is rated on a scale of zero to 5, with higher scores denoting higher motor function. Similarly, the MAL is a valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.	3 months follow up
motor activity log (MAL)	valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.	At baseline
motor activity log (MAL)	valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.	2 weeks
motor activity log (MAL)	valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.	4 weeks
motor activity log (MAL)	valid and reliable instrument comprising of 30 items that separately assess quantity and quality of the use of upper extremity in real world following a stroke. Each of the items contained in the instrument are rated on a scale of zero to 5, with higher scores denoting higher quantity or quality of use of the limb in the real world.	3 months follow up
community integration measure (CIM)	valid and reliable 10-item measure of social interactions following a disease or illness. Each item is rated on a 5 point scale, with possible scores ranging from 0 to 50.	at baseline
community integration measure (CIM)	valid and reliable 10-item measure of social interactions following a disease or illness. Each item is rated on a 5 point scale, with possible scores ranging from 0 to 50.	2 weeks
community integration measure (CIM)	valid and reliable 10-item measure of social interactions following a disease or illness. Each item is rated on a 5 point scale, with possible scores ranging from 0 to 50.	4 weeks
community integration measure (CIM)	valid and reliable 10-item measure of social interactions following a disease or illness. Each item is rated on a 5 point scale, with possible scores ranging from 0 to 50.	3 months follow up
stroke self-efficacy questionnaire (SSEQ)	The SSEQ is a valid and reliable measure of how confident patients with stroke are in carrying out activities of daily living. The most recent version of the questionnaire is scored on a scale of 0 to 3, with higher scores denoting increasing confidence.	at baseline
stroke self-efficacy questionnaire (SSEQ)	The SSEQ is a valid and reliable measure of how confident patients with stroke are in carrying out activities of daily living. The most recent version of the questionnaire is scored on a scale of 0 to 3, with higher scores denoting increasing confidence.	2 weeks
stroke self-efficacy questionnaire (SSEQ)	The SSEQ is a valid and reliable measure of how confident patients with stroke are in carrying out activities of daily living. The most recent version of the questionnaire is scored on a scale of 0 to 3, with higher scores denoting increasing confidence.	4 weeks
stroke self-efficacy questionnaire (SSEQ)	The SSEQ is a valid and reliable measure of how confident patients with stroke are in carrying out activities of daily living. The most recent version of the questionnaire is scored on a scale of 0 to 3, with higher scores denoting increasing confidence.	3 months follow up
stroke specific quality of life (SSQoL)	valid and reliable measure of quality of life specifically for patients with stroke. It consists of 49 items measuring 12 domains.	at baseline
stroke specific quality of life (SSQoL)	valid and reliable measure of quality of life specifically for patients with stroke. It consists of 49 items measuring 12 domains.	2 weeks
stroke specific quality of life (SSQoL)	valid and reliable measure of quality of life specifically for patients with stroke. It consists of 49 items measuring 12 domains.	4 weeks
stroke specific quality of life (SSQoL)	valid and reliable measure of quality of life specifically for patients with stroke. It consists of 49 items measuring 12 domains.	3 months follow up

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Shamay NG, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Disability; Constraint Induced Movement Therapy
• Other Study ID Numbers: 2024-CIMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No