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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04823546
Other study ID # REC/Lhr/20/2048 Anas Arshad
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2020
Est. completion date December 30, 2020

Study information

Verified date March 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 30, 2020
Est. primary completion date October 20, 2020
Accepts healthy volunteers No
Gender All
Age group 55 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
activity based therapy
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;
Strength Training
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

Locations

Country Name City State
Pakistan Binash afzal Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

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. — View Citation

Lamberti N, Straudi S, Malagoni AM, Argirò 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. — View 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. — View Citation

Lund C, Dalgas U, Grønborg 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. — View 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. — View 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. — View 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. — View Citation

Vahlberg B, Cederholm T, Lindmark B, Zetterberg L, Hellström 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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
2 months
Primary 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. 2 months
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