NCT04556903

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

September 16, 2020

Last Update Submit

September 18, 2020

Conditions

Keywords

Bilateral Arm Training (BAT)Stroke

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Bilateral Arm Training

EXPERIMENTAL

Bilateral Arm Training

Combination Product: Bilateral Arm Training

modified constrained induce movement therapy

ACTIVE COMPARATOR

modified constrained induce movement therapy

Combination Product: modified constrained induce movement therapy

Interventions

Bilateral Arm TrainingCOMBINATION_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

Bilateral Arm Training

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

modified constrained induce movement therapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 17954904BACKGROUND
  • 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.

    PMID: 17132052BACKGROUND
  • 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.

    PMID: 424667BACKGROUND
  • 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.

    PMID: 12370871BACKGROUND
  • 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.

    PMID: 16476449BACKGROUND
  • Dobkin BH. Clinical practice. Rehabilitation after stroke. N Engl J Med. 2005 Apr 21;352(16):1677-84. doi: 10.1056/NEJMcp043511.

    PMID: 15843670BACKGROUND
  • 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.

    PMID: 8466415BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Zeest Hashmi, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 21, 2020

Study Start

June 15, 2019

Primary Completion

December 15, 2019

Study Completion

December 30, 2019

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations