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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04820660
Other study ID # REC/Lhr/19/2033 Hira Javed
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date December 30, 2019

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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 30, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers No
Gender All
Age group 45 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Task orientated strengthening training
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.
Balance training exercises
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.

Locations

Country Name City State
Pakistan Riphah IU Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View 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. — View 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. Review. — View 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. Epub 2003 Jul 10. — View 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. — View Citation

van der Worp HB, van Gijn J. Clinical practice. Acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):572-9. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4months
Primary 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. 4 months
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