Comparison of effects of Same Arm Movement Therapy (SAME) Vs Constraint Induced Movement Therapy (CIMT) to improve upper-limb function in chronic Stroke
To compare the effects of Same Arm Movement Therapy (SAME) Vs Constraint Induced Movement Therapy (CIMT) to improve upper-limb function in chronic Stroke.
Design
Randomized clinical trial.
Settings and conduct
Riphah Rehabilitation Center, Spine & Physiotherapy Rehab Centre
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Confirmed infract or Hemorrhage by a neurologist using either MRI or CT scan. Age between 30-65. History of stroke 1–6 months prior to participation in the project. Patients who provided consents to participate in the study. Proper balance and safety while wearing the restraint
Exclusion Criteria:
Patients were not considered for participation in the trial if: They were discharged from hospital within 1 week. Patients with implants such as Neuro stimulator containing electric circurity and implants generating electric sign. Patients with anxiety and claustrophobia with diagnosed psychological disorder. Patients undergoing chemotherapy. Alcohol dependency or evidence of substance abuse. Patients without any visual-perceptual problems. Patients without any communication barriers/language issue. Patients with no significant cognitive impairments
Intervention groups
Group A: SAME Therapy treatment protocol consists of 8 weeks of mental rehearsal of upper limb movements during 45-min supervised sessions three times a week and structured independent sessions twice a week.
Group B: CIMT treatment protocol consists of 8 weeks of daily intensive training of the affected extremity for 2 hours per day, 5 days per week, and 8 weeks in association with restriction of the non-affected extremity for 10 hours a day.
Main outcome variables
Wolf motor function test, Action Research Arm test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200620047848N1
Registration date:2020-10-01, 1399/07/10
Registration timing:registered_while_recruiting
Last update:2020-10-01, 1399/07/10
Update count:0
Registration date
2020-10-01, 1399/07/10
Registrant information
Name
Alina Shaukat
Name of organization / entity
Riphah College of Rehabilitation & Allied Health Sciences
Country
Pakistan
Phone
+92 42 36610923
Email address
alinashaukat07@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-08, 1399/06/18
Expected recruitment end date
2020-11-08, 1399/08/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of Same Arm Movement Therapy (SAME) Vs Constraint Induced Movement Therapy (CIMT) to improve upper-limb function in chronic Stroke
Public title
Comparison of effects of Same Arm Movement Therapy (SAME) Vs Constraint Induced Movement Therapy (CIMT) to improve upper-limb function in chronic Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed infarct or Hemorrhage by a neurologist using either MRI or CT scan
Age between 30-65
History of stroke 1–6 months prior to participation in the project
Patients who provided consents to participate in the study
Proper balance and safety while wearing the restraint
Exclusion criteria:
They were discharged from hospital within 1 week
Patients participating in any experimental rehabilitation on drug studies
Patients with implants such as Neuro stimulator containing electric circurity and implants generating electric sign
Patients with anxiety and claustrophobia with diagnosed psychological disorder
Patients undergoing chemotherapy
Alcohol dependency or evidence of substance abuse
Patients without any visual-perceptual problems
Patients without any communication barriers/language issue
Patients with no significant cognitive impairments
Age
From 30 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by lottery method. Allocation concealment through sealed envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
participant will be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Non- Probability Convenient Sampling will be used to recruit the individuals for the study and then randomization will be done by lottery method to divide the individuals into 2 treatment groups. Sealed envelope will be used for allocation concealment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah College of Rehabilitation & Allied health Sciences
Total 8 week program and No followup. Primary outcome will be measured on 8th week.
Method of measurement
Wolf motor function test, Action Research Arm Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: SAME Therapy treatment protocols consist of 8 weeks of mental rehearsals of upper limb movements during 45-mints supervised sessions three times a week and structural independent sessions twice a week.
Category
Rehabilitation
2
Description
Intervention group B: CIMT treatment protocol consists of 8 weeks of daily intensive training of the affected extremity for 2 hours per day, 5 days per week, and 8 weeks in association with restriction of the non-affected extremity for 10 hours a day.