- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04823546
Comparison of Effects of Activity Base Therapy vs Strength Training on Gait Performance in Chronic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
- Binash Afzal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Activity based therapy
Activity based training was done in 2 phases. exercise involve
(10) Walking on a treadmill; |
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;
|
|
Active Comparator: strength training
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Up and Go Test (TUG)
Time Frame: 2 months
|
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. |
2 months
|
|
Fugl meyer for lower limb
Time Frame: 2 months
|
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.
|
2 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Geiger M, Supiot A, Zory R, Aegerter P, Pradon D, Roche N. The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial. Trials. 2017 Oct 23;18(1):492. doi: 10.1186/s13063-017-2219-6.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Wist S, Clivaz J, Sattelmayer M. Muscle strengthening for hemiparesis after stroke: A meta-analysis. Ann Phys Rehabil Med. 2016 Apr;59(2):114-24. doi: 10.1016/j.rehab.2016.02.001. Epub 2016 Mar 8.
- Chan K, Phadke CP, Stremler D, Suter L, Pauley T, Ismail F, Boulias C. The effect of water-based exercises on balance in persons post-stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 May;24(4):228-235. doi: 10.1080/10749357.2016.1251742. Epub 2016 Nov 3.
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/20/2048 Anas Arshad
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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