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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04556903
Other study ID # REC/00297 Zobia khan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2019
Est. completion date December 30, 2019

Study information

Verified date September 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date December 30, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
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
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

Locations

Country Name City State
Pakistan Riphah International University Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Andrews K, Stewart J. Stroke recovery: he can but does he? Rheumatol Rehabil. 1979 Feb;18(1):43-8. — View Citation

Bonita R, Beaglehole R. Stroke prevention in poor countries: time for action. Stroke. 2007 Nov;38(11):2871-2. Epub 2007 Oct 22. — View Citation

Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. Review. — View Citation

Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. — View Citation

Sterr A, Elbert T, Berthold I, Kölbel 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. — View 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. Epub 2006 Feb 14. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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, 1 hour
Primary 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 1 hour
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