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Effects of m CIMT and Bilateral Arm Training on Upper Extremity Chronic Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Bilateral Arm Training
modified constrained induce movement therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Bilateral Arm Training (BAT), Stroke

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to follow instruction & 2 steps command(Mini mental state score > 22)
  • At least 6 month after stroke

Exclusion Criteria:

  • Spasticity, defined as a score of 3 or more on Modified As worth scale (MAS)
  • Uncontrolled hypertension (190/110 mm Hg)

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bilateral Arm Training

modified constrained induce movement therapy

Arm Description

Bilateral Arm Training

modified constrained induce movement therapy

Outcomes

Primary Outcome Measures

Action Research arm test
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery,
Fugl-Meyer assessment test (Upper Extremity Section)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based ... of three evidence based strategies to increase upper extremity function

Secondary Outcome Measures

Full Information

First Posted
September 16, 2020
Last Updated
September 18, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04556903
Brief Title
Effects of m CIMT and Bilateral Arm Training on Upper Extremity Chronic Stroke Patients
Official Title
Comparative Effects of Modified Constraint Induced Movement Therapy and Bilateral Arm Training on Upper Extremity in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare and evaluate the effects of Modified Constraint Induced Movement Therapy (mCIMT) & Bilateral Arm Training on upper extremity in chronic stroke patients this study will be conducted
Detailed Description
Stroke is the abrupt loss of neurological function, due to disturbance of the blood flow in the brain. There is variety of crucial sign and symptoms that can occur during stroke include changes in the level of consciousness and impairments of sensation and motor or cognitive function loss. It also includes changes in perceptual and language functions. Worldwide, 55 million people died of stroke in 2002, and approximately 20 percent of these deaths occurred in South Asia. Predicting amounts of deaths from stroke will increase to 63 million in 2015 and 78 million by 2030 with the mass occurring in the poor countries of the world. Rehabilitation plays a major role in minimizing activity limitation and participation restriction or to decrease extent of impairments. Stroke can cause variety of impairments which have greater impact on the patient quality of life. Hemiparesis is the common impairment, in which involvement of upper limb is commonly seen. mCIMT and BAT techniques both play an important role in the treatment of stroke. In this research, both techniques will be use to evaluate which treatment technique is better for upper extremity chronic stroke patients. Written informed consent will be taken. Each participant will be requested to draw either number one or number two from a box. Number one will be allocated to Group A and number two will be allocated to group B. The A group will receive mCIMT after applying conservative management and Group B will receive BAT for 5 days a week for 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Bilateral Arm Training (BAT), Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each participant will be requested to draw either number one or number two from a box. Number one will be allocated to Group A and number two will be allocated to group B. The A group will receive mCIMT after applying conservative treatment and Group B will receive BAT for 5 days a week for 8 weeks.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral Arm Training
Arm Type
Experimental
Arm Description
Bilateral Arm Training
Arm Title
modified constrained induce movement therapy
Arm Type
Active Comparator
Arm Description
modified constrained induce movement therapy
Intervention Type
Combination Product
Intervention Name(s)
Bilateral Arm Training
Intervention Description
First component of mCIMT will comprise one hour activity and a rest period of five minute given between each ten minutes of task practice. These activities will base on activities of daily living (ADL'S) and I
Intervention Type
Combination Product
Intervention Name(s)
modified constrained induce movement therapy
Intervention Description
BAT involves in four sessions, each session involve repetitive practice of bilateral tasks for one hour and a rest period of 5 minutes. The tasks are: Block placement- 10minutes Peg targeting- 10 minutes Peg inversion-10miutes Transferring objects- 10minutes
Primary Outcome Measure Information:
Title
Action Research arm test
Description
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery,
Time Frame
1 hour
Title
Fugl-Meyer assessment test (Upper Extremity Section)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based ... of three evidence based strategies to increase upper extremity function
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to follow instruction & 2 steps command(Mini mental state score > 22) At least 6 month after stroke Exclusion Criteria: Spasticity, defined as a score of 3 or more on Modified As worth scale (MAS) Uncontrolled hypertension (190/110 mm Hg)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeest Hashmi, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17954904
Citation
Bonita R, Beaglehole R. Stroke prevention in poor countries: time for action. Stroke. 2007 Nov;38(11):2871-2. doi: 10.1161/STROKEAHA.107.504589. Epub 2007 Oct 22. No abstract available.
Results Reference
background
PubMed Identifier
17132052
Citation
Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
Results Reference
background
PubMed Identifier
424667
Citation
Andrews K, Stewart J. Stroke recovery: he can but does he? Rheumatol Rehabil. 1979 Feb;18(1):43-8. doi: 10.1093/rheumatology/18.1.43. No abstract available.
Results Reference
background
PubMed Identifier
12370871
Citation
Sterr A, Elbert T, Berthold I, Kolbel S, Rockstroh B, Taub E. Longer versus shorter daily constraint-induced movement therapy of chronic hemiparesis: an exploratory study. Arch Phys Med Rehabil. 2002 Oct;83(10):1374-7. doi: 10.1053/apmr.2002.35108.
Results Reference
background
PubMed Identifier
16476449
Citation
Stewart KC, Cauraugh JH, Summers JJ. Bilateral movement training and stroke rehabilitation: a systematic review and meta-analysis. J Neurol Sci. 2006 May 15;244(1-2):89-95. doi: 10.1016/j.jns.2006.01.005. Epub 2006 Feb 14.
Results Reference
background
PubMed Identifier
15843670
Citation
Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.
Results Reference
background
PubMed Identifier
8466415
Citation
Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.
Results Reference
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Effects of m CIMT and Bilateral Arm Training on Upper Extremity Chronic Stroke Patients

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