Effects of Home-based CIMT and Clinic-based CIM on Stroke
ConditionMotor Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorThe Hong Kong Polytechnic University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based CIMT
DeviceParticipants 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
DeviceParticipants 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
DeviceParticipants 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
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: Home-based CIMTExperimental treatment 1 intervention
Group B: Clinic-based CIMTExperimental treatment 1 intervention
Group C: ControlPlacebo comparator 1 intervention
Trial outcomes
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 baseline2
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 weeks3
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 weeks4
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 upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov