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Task-oriented Progressive Resistance Strength Training and Balance Exercises on Lower Limb in Individuals With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Task orientated strengthening training
Balance training exercises
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 Balance, progressive resistance strength training

Eligibility Criteria

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

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.

Sites / Locations

  • Riphah IU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Task oriented Strength training group

Balance Training

Arm Description

Standing and reaching in different directions Sit-to-stand Stepping forward and backward Stepping sideways onto blocks

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

Outcomes

Primary Outcome Measures

Berg Balance Scale (BBS)
Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56.
Fugl Meyer Assessment Lower Extremity
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.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2021
Last Updated
March 29, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04820660
Brief Title
Task-oriented Progressive Resistance Strength Training and Balance Exercises on Lower Limb in Individuals With Stroke
Official Title
Effects of Task-oriented Progressive Resistance Strength Training and Balance Exercises in Functional Performance on Lower Limb in Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
October 30, 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
Yes

5. Study Description

Brief Summary
Stroke is ranked as the number fifth cause of death and a main cause of disability in the United States. It affects the arteries which supply blood to and within the brain. If the blood supply to the brain is disrupted, it will not be able to receive oxygen and the nutrients which are transported by those arteries. This leads to the death of brain cells having a magnificent effect on the function of that part.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Balance, progressive resistance strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Task oriented Strength training group
Arm Type
Experimental
Arm Description
Standing and reaching in different directions Sit-to-stand Stepping forward and backward Stepping sideways onto blocks
Arm Title
Balance Training
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Task orientated strengthening training
Intervention Description
Standing and reaching in different directions for objects located beyond arm's length to promote loading of the lower limbs and activation of lower limb muscles; Sit-to-stand from various chair heights to strengthen the lower limb extensor muscles; Stepping forward and backward onto blocks of various heights to strengthen the lower limb muscles; Stepping sideways onto blocks of various heights to strengthen the lower limb muscles; forward step-up onto blocks of various heights to strengthen the lower limb muscles; heel(s) raise and lower while maintaining in a standing posture to strengthen the plantar- flexor muscles. Each workstation was 5 min in duration for each exercise class. Each subject participated in a one-to-one therapy.
Intervention Type
Other
Intervention Name(s)
Balance training exercises
Intervention Description
Stepping forward, backward, and sideways on the exercise step; Stepping over blocks of various heights; Standing up from a chair, walking four steps forward, performing a bilateral stool touch and walking backwards to the chair; Standing up from a chair, walking four steps forward, turning to the right, stepping over the exercise step, turning to the right again and walking forwards to the chair (repeat the exercise circuit in opposite direction); From a sitting position on a 65-cm Swiss ball, performing a range of motion and balance exercises (forward and backward rolling of the Arms; bending the trunk forward and side to side); Performing double-legged stance for 10 s; Performing tandem stance for 10 s; Rising from a chair without the use of the arms; Walking forward and backward with a tandem walking pattern (toes of one foot touching the heel of the foot in front); Performing single- legged stance for 10 s.
Primary Outcome Measure Information:
Title
Berg Balance Scale (BBS)
Description
Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56.
Time Frame
4months
Title
Fugl Meyer Assessment Lower Extremity
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabiya Noor, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah IU
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21571152
Citation
Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
Results Reference
background
PubMed Identifier
7477192
Citation
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.
Results Reference
background
PubMed Identifier
17687132
Citation
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.
Results Reference
background
PubMed Identifier
19359645
Citation
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.
Results Reference
background
PubMed Identifier
12444191
Citation
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.
Results Reference
background
PubMed Identifier
12855835
Citation
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.
Results Reference
background

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Task-oriented Progressive Resistance Strength Training and Balance Exercises on Lower Limb in Individuals With Stroke

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