Clinical trial NCT06465251: Effects of Home-based CIMT and Clinic-based CIM on Stroke
Official title: Effects of Repetition Home-based Constraint Induced Movement Therapy (CIMT) Compared With Repetition Clinic-based CIMT on Outcomes Post Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motor Function
Keywords: Constraint Induced Movement Therapy
Disability
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: upper limb Fugl Meyer motor assessment
timeFrame: at baseline
measure: upper limb Fugl Meyer motor assessment
timeFrame: 2 weeks
measure: upper limb Fugl Meyer motor assessment
timeFrame: 4 weeks
measure: upper limb Fugl Meyer motor assessment
timeFrame: 3 months follow up
measure: Wolf motor function test (WMFT)
timeFrame: at baseline
measure: Wolf motor function test (WMFT)
timeFrame: 2 weeks
measure: Wolf motor function test (WMFT)
timeFrame: 4 weeks
measure: Wolf motor function test (WMFT)
timeFrame: 3 months follow up
measure: motor activity log (MAL)
timeFrame: At baseline
measure: motor activity log (MAL)
timeFrame: 2 weeks
measure: motor activity log (MAL)
timeFrame: 4 weeks
measure: motor activity log (MAL)
timeFrame: 3 months follow up
measure: community integration measure (CIM)
timeFrame: at baseline
measure: community integration measure (CIM)
timeFrame: 2 weeks
measure: community integration measure (CIM)
timeFrame: 4 weeks
measure: community integration measure (CIM)
timeFrame: 3 months follow up
measure: stroke self-efficacy questionnaire (SSEQ)
timeFrame: at baseline
measure: stroke self-efficacy questionnaire (SSEQ)
timeFrame: 2 weeks
measure: stroke self-efficacy questionnaire (SSEQ)
timeFrame: 4 weeks
measure: stroke self-efficacy questionnaire (SSEQ)
timeFrame: 3 months follow up
measure: stroke specific quality of life (SSQoL)
timeFrame: at baseline
measure: stroke specific quality of life (SSQoL)
timeFrame: 2 weeks
measure: stroke specific quality of life (SSQoL)
timeFrame: 4 weeks
measure: stroke specific quality of life (SSQoL)
timeFrame: 3 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Shamay Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: