- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04820660
Task-oriented Progressive Resistance Strength Training and Balance Exercises on Lower Limb in Individuals With Stroke
Effects of Task-oriented Progressive Resistance Strength Training and Balance Exercises in Functional Performance on Lower Limb in Individuals With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was quasi-experimental trial, to compare the effectiveness of Progressive Resistive Strength Exercises and Balance Exercises in subjects with Stroke. Subjects with Stroke meeting the predetermined inclusion & exclusion criteria were divided into two groups using lottery method. Pre assessment was done using Berg Balance Scale, Fugl Meyer Assessment - Lower Extremity and Step Test.
Subjects in one group were treated with Progressive Resistive Strength Training and other group was treated with Balance training. Each subject received 12 treatment sessions, with 03 treatment sessions per week. Results were recorded at the end of 3rd, 6th, 9th and 12th treatment sessions. Recorded values were analysed using SPSS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah IU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hemiparetic from a single stroke occurring at least a year earlier, not presently receiving any rehabilitation services,
- Participants should not be receiving any rehabilitation services
- Participants should be able to walk 10 m independently without an assistive device
- Participants should be medically stable enough to allow participation, and able to understand instructions and follow commands.
Exclusion Criteria:
- Participants with any medical condition that would prevent participation in the training program
- Participants with any uncontrolled health condition for which exercise is contraindicated.
- Participants with any tumor or neurological signs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Task oriented Strength training group
Standing and reaching in different directions Sit-to-stand Stepping forward and backward Stepping sideways onto blocks
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Each workstation was 5 min in duration for each exercise class. Each subject participated in a one-to-one therapy. |
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Experimental: Balance Training
Stepping forward, backward, and sideways on the exercise step; Stepping over blocks of various heights; Standing up from a chair, From a sitting position on a 65-cm Swiss ball, Arms; bending the trunk forward and side to side); Performing double-legged stance Performing tandem stance Rising from a chair without the use of the arms; Walking forward and backward with a tandem walking pattern Performing single- legged stance
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Berg Balance Scale (BBS)
Time Frame: 4months
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Zero indicates the lowest level of function and 4 the highest level of function.
The total score ranges from 0 to 56.
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4months
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Fugl Meyer Assessment Lower Extremity
Time Frame: 4 months
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Scoring is based on direct observation of performance.
Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.
The total possible scale score is 226.
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4 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.
- Albers GW, Caplan LR, Easton JD, Fayad PB, Mohr JP, Saver JL, Sherman DG; TIA Working Group. Transient ischemic attack--proposal for a new definition. N Engl J Med. 2002 Nov 21;347(21):1713-6. doi: 10.1056/NEJMsb020987. No abstract available.
- van der Worp HB, van Gijn J. Clinical practice. Acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):572-9. doi: 10.1056/NEJMcp072057. No abstract available.
- Andersen KK, Olsen TS, Dehlendorff C, Kammersgaard LP. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009 Jun;40(6):2068-72. doi: 10.1161/STROKEAHA.108.540112. Epub 2009 Apr 9.
- Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. doi: 10.1161/01.STR.0000080935.01264.91. Epub 2003 Jul 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/19/2033 Hira Javed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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