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

NCT ID: NCT06465251

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-12-01

Brief Summary

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.

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

Conditions

Motor Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Home-based CIMT

Intervention Type: DEVICE

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.

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

Group Type: EXPERIMENTAL

Clinic-based CIMT

Intervention Type: DEVICE

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

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Shamay Ng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shamay Ng, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Shamay NG, PhD

Role: CONTACT

shamay.ng@polyu.edu.hk

+852 2766-4889

Facility Contacts

Shamay Ng, PhD

Role: primary

Shamay.Ng@polyu.edu.hk

27664889

Other Identifiers

2024-CIMT

Identifier Type: -

Identifier Source: org_study_id