Comparison of modified Constraint Induced Movement Therapy (mCIMT) and mirror therapy (MT) in addition to neuromuscular electrical stimulation (NMES) on upper extremity function of chronic stroke patients.
To compare the effect of modified constraint induced movement therapy with mirror therapy in addition to neuromuscular electrical stimulation on upper extremity of chronic stroke patients
Design
Randomized Control Trial (RCT) Single blind study
Study groups: mCIMT group and MT+NMES group Phase: N.A Sample size : 20
Randomization: In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The study is single blinded as participants is not aware of the intervention group they are placed in. Study center: Single center study
Settings and conduct
Smart Medical & Diagnostic Center Islamabad. Physiotherapy department
In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The study is single blinded as participants is not aware of the intervention group they are placed in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 40 to 65 years; both gender; Hemiplegic stroke patients past 6 months; minimal function of hand includes 10° wrist extension, 10° thumb extension, 10° finger extension; absence of severe attentive deficit; will able to understand and follow simple verbal instructions; have no severe cognitive disorder that interferes with the study.
Exclusion criteria: upper limb fracture; peripheral nerve injury; Apraxia; visual field defect; serious cardiac disease ( arrhythmias and pacemakers); skin or peripheral circulation disorder; those who participate in other studies or rehabilitation program; chronic synergies.
Intervention groups
There are 2 groups A and B.
Group A : modified CIMT group; Group B: Mirror therapy MT group
Main outcome variables
1. Modified Barthel Index
2. Wolf Motor Function test
3. Upper Limb Motor assessment Scale
General information
Reason for update
Acronym
Nill
IRCT registration information
IRCT registration number:IRCT20211022052835N2
Registration date:2022-01-10, 1400/10/20
Registration timing:retrospective
Last update:2022-01-10, 1400/10/20
Update count:0
Registration date
2022-01-10, 1400/10/20
Registrant information
Name
Fouzia Batool
Name of organization / entity
Shifa Tameer-e-Millat University
Country
Pakistan
Phone
+92 51 8441752
Email address
fouzia_dpt.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-19, 1400/04/28
Expected recruitment end date
2021-08-16, 1400/05/25
Actual recruitment start date
2021-07-26, 1400/05/04
Actual recruitment end date
2021-08-23, 1400/06/01
Trial completion date
2021-08-23, 1400/06/01
Scientific title
Comparison of modified Constraint Induced Movement Therapy (mCIMT) and mirror therapy (MT) in addition to neuromuscular electrical stimulation (NMES) on upper extremity function of chronic stroke patients.
Public title
Comparison of modified Constraint Induced Movement Therapy (mCIMT) and mirror therapy (MT) in addition to neuromuscular electrical stimulation (NMES) on upper extremity function of chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40 to 65 years
Both gender
Hemiplegic stroke patients past 6 months
Minimal function of hand includes 10° wrist extension, 10° thumb extension, 10° finger extension
Absence of severe attentive deficit
Will able to understand and follow simple verbal instructions
Have no severe cognitive disorder that interferes with the study.
Exclusion criteria:
Upper limb fracture
Peripheral nerve injury
Apraxia
Visual field defect
A serious cardiac disease ( arrhythmias and pacemakers)
Skin or peripheral circulation disorder
Those who participate in other studies or rehabilitation program.
Chronic synergies
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
34
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Random numbers is written on index cards and placed in thick and opaque sealed envelops before the study. After taking consent from the patient for their participation in the study, the therapist opens the envelop and give the respective treatments to the patients . The study is single blinded as participants is not aware of the intervention group they are placed in.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are single blinded as they don't know which treatment plan or intervention is given to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board and ethical committee shifa tameer-e-millat and shifa international hospi
Street address
Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad
City
Islamabad
Postal code
44000
Approval date
2021-07-16, 1400/04/25
Ethics committee reference number
IRB#182-21
Health conditions studied
1
Description of health condition studied
Only diagnosed hemiplegic stroke patients past 6 months who do have minimal function of hand thumb and fingers.
ICD-10 code
G81.90
ICD-10 code description
Hemiplegia, unspecified affecting unspecified side
Primary outcomes
1
Description
To compare the effect of modified constraint induced movement therapy with mirror therapy in addition to neuromuscular electrical stimulation on upper extremity of chronic stroke patients.
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Modified barthel index , Wolf motor scale and Upper limb Motor assessment scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A is given mCIMT treatment. This group received modified constraint-Induced therapy for 4 sessions per week for 4 weeks, applied for 30 minutes. Patient wore a mitt on his/her unaffected arm.Patient performed repetitive task training with his/her affected arm such as picking up the ball from the basket and placing it back, picking up the coins, counting numbers on finger, slowly opening and closing of fist, turning of palm. Patient was also advised to keep performing activities with his/her paretic arm while wearing the mitt on less affected arm at home as well.
Category
Rehabilitation
2
Description
Intervention group B. This group received mirror therapy (MT) in addition to NMES.Mirror therapy 4 sessions per week for 4 weeks applied for 30 minutes. Activity based therapy was done like opening and closing of fist, touching thumb with the tip of each finger, wipe the table with washcloth in circular motion, back and forth, up and down, picking up the coins. Along with this, NMES was applied on extensor muscles of wrist and hand for 20 minutes for which frequency was set between 20-50 Hz, with 30-70 mA intensity lasted for 8 seconds and then stopped for 8 seconds.