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

NCT06465251 | Recruiting

• 1 other identifier: 2024-CIMT
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Function

Keywords

Constraint Induced Movement Therapy; Disability

Outcome Measures

Primary Outcomes (24)

• 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

Study Arms (3)

Home-based CIMT

EXPERIMENTAL

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

Clinic-based CIMT

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Home-based CIMT 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.

Home-based CIMT

Clinic-based CIMT 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

Clinic-based CIMT

Control 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

Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Shamay Ng, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shamay NG, PhD

CONTACT

+852 2766-4889; shamay.ng@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

HK (1)