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Comparison of Effects of Activity Base Therapy vs Strength Training on Gait Performance in Chronic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
activity based therapy
Strength Training
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 Activity based therapy, Chronic stroke, Gait, strength training, exercises

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants were at least 6 months post stroke.
  • Ability to walk independent or with help of walking aids
  • Ischemic stroke patients included in study.
  • Mini mental state examination patients fully understand the commands

Exclusion Criteria:

  • Presence of orthopaedic problems.

    • Neurological disorders.
    • Psychological problems.
    • Cognitive issues.
    • People with severe visual issues.
    • Participants with other medical complications foot ulcers, orthopaedic or other neurological impedance

Sites / Locations

  • Binash afzal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Activity based therapy

strength training

Arm Description

Activity based training was done in 2 phases. exercise involve Standing and reaching Sit-to-stand Stepping forward and backward Phase 2 Phase 2 started after 3 weeks. Phase 2 included the phase 1 exercise along with below exercise. (10) Walking on a treadmill;

Strength training for hip • flexor and extensors and abductors, knee extensors, and ankle dorsi flexors and plantar •flexors. Apart from using body weight, sandbag weights and Therabands of eight different resistances

Outcomes

Primary Outcome Measures

Time Up and Go Test (TUG)
Simple screening test that is a sensitive and specific measure of probability for falls among older adultsThe Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Fugl meyer for lower limb
The fugal-meyer assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning in patient with post stroke hemiplegia.

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
NCT04823546
Brief Title
Comparison of Effects of Activity Base Therapy vs Strength Training on Gait Performance in Chronic Stroke
Official Title
Comparison of Effects of Activity Base Therapy vs Strength Training on Gait Performance in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
December 30, 2020 (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 a leading cause of disability worldwide affecting both male and female especially in older people. Functional independence and locomotion are hampered in stroke, therefore, affecting their quality of life. Objective: To find the comparative effects of activity base therapy vs strength training on gait performance in chronic stroke patients.
Detailed Description
It was a randomized controlled trial, conducted in physical therapy department of Sir Ganga Ram Hospital. 20 chronic stroke patients were equally divided into two groups. In group-A patients were treated with activity base therapy and in group-B patients were treated with strength training. Patients were treated for a total of 6 weeks (12 sessions), 1 hour in a day, 3 times per week. Patients were assessed using Timed Up and Go (TUG) test and Fugl Meyer Examination-Lower Extremity (FME-LE). SPSS 25 was used toanalyze the dat

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Activity based therapy, Chronic stroke, Gait, strength training, exercises

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Activity based therapy
Arm Type
Experimental
Arm Description
Activity based training was done in 2 phases. exercise involve Standing and reaching Sit-to-stand Stepping forward and backward Phase 2 Phase 2 started after 3 weeks. Phase 2 included the phase 1 exercise along with below exercise. (10) Walking on a treadmill;
Arm Title
strength training
Arm Type
Active Comparator
Arm Description
Strength training for hip • flexor and extensors and abductors, knee extensors, and ankle dorsi flexors and plantar •flexors. Apart from using body weight, sandbag weights and Therabands of eight different resistances
Intervention Type
Other
Intervention Name(s)
activity based therapy
Intervention Description
Standing and reaching (2) Sit-to-stand (3) Stepping forward and backward onto blocks (4) Stepping sideways onto blocks (5) Forward step up onto blocks (6) Raising and lowering of heel (7) Standing with the base of support constrained with feet in parallel and tandem conditions Phase 2 started after 3 weeks. Phase 2 included the phase 1 exercise along with below exercise. (10) Walking on a treadmill; (11) Walking over various surfaces and obstacles;
Intervention Type
Other
Intervention Name(s)
Strength Training
Intervention Description
Strength training included for hip • flexor and extensors and abductors, knee extensors, and ankle dorsi flexors and plantar •flexors. Apart from using body weight, sandbag weights and Therabands of eight different resistances
Primary Outcome Measure Information:
Title
Time Up and Go Test (TUG)
Description
Simple screening test that is a sensitive and specific measure of probability for falls among older adultsThe Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
Time Frame
2 months
Title
Fugl meyer for lower limb
Description
The fugal-meyer assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning in patient with post stroke hemiplegia.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants were at least 6 months post stroke. Ability to walk independent or with help of walking aids Ischemic stroke patients included in study. Mini mental state examination patients fully understand the commands Exclusion Criteria: Presence of orthopaedic problems. Neurological disorders. Psychological problems. Cognitive issues. People with severe visual issues. Participants with other medical complications foot ulcers, orthopaedic or other neurological impedance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, PHD*
Organizational Affiliation
Riphah international university lahore campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Binash afzal
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31256082
Citation
Saleh MSM, Rehab NI, Aly SMA. Effect of aquatic versus land motor dual task training on balance and gait of patients with chronic stroke: A randomized controlled trial. NeuroRehabilitation. 2019;44(4):485-492. doi: 10.3233/NRE-182636.
Results Reference
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29448162
Citation
Tisserand R, Armand S, Allali G, Schnider A, Baillieul S. Cognitive-motor dual-task interference modulates mediolateral dynamic stability during gait in post-stroke individuals. Hum Mov Sci. 2018 Apr;58:175-184. doi: 10.1016/j.humov.2018.01.012. Epub 2018 Mar 12.
Results Reference
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PubMed Identifier
30370752
Citation
Park HK, Lee HJ, Lee SJ, Lee WH. Land-based and aquatic trunk exercise program improve trunk control, balance and activities of daily living ability in stroke: a randomized clinical trial. Eur J Phys Rehabil Med. 2019 Dec;55(6):687-694. doi: 10.23736/S1973-9087.18.05369-8. Epub 2018 Oct 29.
Results Reference
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PubMed Identifier
28597708
Citation
Lund C, Dalgas U, Gronborg TK, Andersen H, Severinsen K, Riemenschneider M, Overgaard K. Balance and walking performance are improved after resistance and aerobic training in persons with chronic stroke. Disabil Rehabil. 2018 Oct;40(20):2408-2415. doi: 10.1080/09638288.2017.1336646. Epub 2017 Jun 9.
Results Reference
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PubMed Identifier
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Citation
Lee HS, Park YJ, Park SW. The Effects of Virtual Reality Training on Function in Chronic Stroke Patients: A Systematic Review and Meta-Analysis. Biomed Res Int. 2019 Jun 18;2019:7595639. doi: 10.1155/2019/7595639. eCollection 2019.
Results Reference
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PubMed Identifier
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Citation
Lamberti N, Straudi S, Malagoni AM, Argiro M, Felisatti M, Nardini E, Zambon C, Basaglia N, Manfredini F. Effects of low-intensity endurance and resistance training on mobility in chronic stroke survivors: a pilot randomized controlled study. Eur J Phys Rehabil Med. 2017 Apr;53(2):228-239. doi: 10.23736/S1973-9087.16.04322-7. Epub 2016 Sep 14.
Results Reference
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PubMed Identifier
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Citation
Vahlberg B, Cederholm T, Lindmark B, Zetterberg L, Hellstrom K. Short-term and long-term effects of a progressive resistance and balance exercise program in individuals with chronic stroke: a randomized controlled trial. Disabil Rehabil. 2017 Aug;39(16):1615-1622. doi: 10.1080/09638288.2016.1206631. Epub 2016 Jul 14.
Results Reference
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Citation
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Citation
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Comparison of Effects of Activity Base Therapy vs Strength Training on Gait Performance in Chronic Stroke

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