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CompletedNCT06465251Updated Oct 13, 2026

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

An interventional study of Home-based CIMT and Clinic-based CIMT in Motor Function, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2024, registered Jun 2024).
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Motor Function

Keywords

  • Constraint Induced Movement Therapy
  • Disability
03

In context

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 676 studies on the registry; 254 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
96 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DeviceHome-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.

  • DeviceClinic-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

  • DeviceControl

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at baseline

  2. 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.

    Time frame: 2 weeks

  3. 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.

    Time frame: 4 weeks

  4. 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.

    Time frame: 3 months follow up

  5. 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.

    Time frame: at baseline

  6. 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.

    Time frame: 2 weeks

  7. 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.

    Time frame: 4 weeks

  8. 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.

    Time frame: 3 months follow up

  9. 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.

    Time frame: At baseline

  10. 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.

    Time frame: 2 weeks

  11. 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.

    Time frame: 4 weeks

  12. 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.

    Time frame: 3 months follow up

  13. 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.

    Time frame: at baseline

  14. 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.

    Time frame: 2 weeks

  15. 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.

    Time frame: 4 weeks

  16. 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.

    Time frame: 3 months follow up

  17. 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.

    Time frame: at baseline

  18. 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.

    Time frame: 2 weeks

  19. 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.

    Time frame: 4 weeks

  20. 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.

    Time frame: 3 months follow up

  21. 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.

    Time frame: at baseline

  22. 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.

    Time frame: 2 weeks

  23. 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.

    Time frame: 4 weeks

  24. 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.

    Time frame: 3 months follow up

07

Study locations

1 site
  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06465251
Responsible party
Shamay Ng (Professor, The Hong Kong Polytechnic University) — Principal investigator
First posted
Jun 18, 2024
Start date
Mar 1, 2024
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025
Last update
Oct 13, 2026

Study contacts

Shamay Ng, PhD
principal investigator · The Hong Kong Polytechnic University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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