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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04752124
Other study ID # 555
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2020
Est. completion date March 15, 2021

Study information

Verified date March 2021
Source Government College University Faisalabad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stroke is one of the major cause of morbidity and mortality and the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen. The purpose of this study is to Determine the effect of high intensity speed based treadmill training on Balance, Walking capacity and quality of life in sub-acute stroke.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 15, 2021
Est. primary completion date February 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - age 40-80 years; first episode of stroke; >4 weeks of stroke onset; hemiparesis resulting from unilateral ischaemic stroke; Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively; mini-mental state examination score =23; ability to perform independent walking for at least five minutes with or without an assistive device (FAC=3). All patients will be determined to be in stable cardiovascular condition with a low although slightly greater risk for vigorous exercise than for apparently healthy persons (class B according to the American College of Sports Medicine [ACSM]).13 Exclusion Criteria: - Participants will be excluded from the study if they had any of the following: (1) chronic cardiorespiratory or metabolic diseases; (2) severe osteoporosis; and (3) lesions pertaining to the brainstem or cerebellum; (4) having resting blood pressure above 160/100 mmHg even after taking medications; (5) cardiovascular comorbidity (aortic stenosis, depression of ST-segment, heart failure, arrhythmias, unstable angina, hypertrophic cardio-myopathy); (6) transient ischemic attack; (7) by-pass surgery in the recent three months; and (8) other musculoskeletal problems that prevented the participants from doing aerobic activity.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise Therapy
High intensity speed based interval treadmill training
conventional therapy
conventional physical therapy

Locations

Country Name City State
Pakistan Bin Inam Rehabilitation Center. Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Government College University Faisalabad

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Lau KW, Mak MK. Speed-dependent treadmill training is effective to improve gait and balance performance in patients with sub-acute stroke. J Rehabil Med. 2011 Jul;43(8):709-13. doi: 10.2340/16501977-0838. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 6 minute walk test To determine the endurance after stroke 6 weeks of training
Secondary Berg Balance scale It is used to measure the Balance and stability of patient. Total score of the scale is 56. A score of < 45 indicates individuals may be at greater risk of falling. 5 weeks
Secondary Stroke Impact scale To measure the impairment and quality of life after stroke. The maximum score is 140. 5 weeks
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