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

NCT ID: NCT04556903

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2019-12-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bilateral Arm Training

Bilateral Arm Training

Group Type: EXPERIMENTAL

Bilateral Arm Training

Intervention Type: COMBINATION_PRODUCT

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

modified constrained induce movement therapy

modified constrained induce movement therapy

Group Type: ACTIVE_COMPARATOR

modified constrained induce movement therapy

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Bilateral Arm Training

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

modified constrained induce movement therapy

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

Intervention Type: COMBINATION_PRODUCT

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeest Hashmi, MS

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Islamabad, Federal, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 17954904 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17132052 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 424667 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12370871 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16476449 (View on PubMed)

Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.

Reference Type: BACKGROUND

PMID: 15843670 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8466415 (View on PubMed)

Other Identifiers

REC/00297 Zobia khan

Identifier Type: -

Identifier Source: org_study_id