Universal Exercise Unit Therapy With Sling Exercise Therapy on Lower Limb Kinematics in Chronic Stroke Patients

Not Applicable

Recruiting

• Conditions: Chronic Stroke
• Interventions: Other: Universal Exercise Unit Therapy (UEU); Other: Sling Exercise Therapt (SET); Other: Routine Physical Therapy / Control Group

• Registration Number: NCT05033873
• Lead Sponsor: Riphah International University

Brief Summary

Stroke occurred when blood supply to brain or a part of brain is disturbed due to clot (ischaemic stroke) or due rupture of small vessels (hemorrhagic stroke) in brain and causes bleeding in brain cells. The prevalence of stroke was 1.2 % (1200/100,000) in Pakistan, 3.1% in China and it is 44.29 to 559/100,000 in different parts of the world. Leading cause of stroke is hypertension. The aim of study will be to compare universal exercise unit therapy with sling exercise therapy on lower limb kinematics, disability, balance and quality of life in chronic stroke patients.

Detailed Description

This will be randomized controlled trial. Study will be conducted at Khawaja Arshed Hospital Sargodha. Duration of intervention will be 08 weeks, 5 sessions in a week, total 40 sessions. Duration of single session will be one hour. A convenient sample of n patients fulfilling the inclusion and exclusion criteria will be selected from in-patient settings of various hospitals from the city Sargodha and will be allocated randomly into three groups equally after taking informed consent. Group A will obtain Universal Exercise Unit Therapy. Group B will obtain Sling Exercise Therapy and Group C will be control and will receive routine physical therapy. Outcome will be measured at baseline, 04 weeks and 08 weeks. Outcome measurement tools will be Berg balance scale, Barthel index, Short form 12 (SF-12), Trunk impairment scale, functional reach test and smart phone motion analysis for lower limb kinematics. Scores will be measure in mean and SD. Results of intervention will be comparing by using one way ANOVA by using IBM SPSS version 21.0

Study Timeline

• Study First Submitted: 2021-06-26
• Study Start: 2021-07-15
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-07
• Last Update Posted: 2022-12-08
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patient with chronic (course of disease at least six month)
• Recently discharge from in-patients setting with in 06 month of onset
• Hemiplegia (either right or left)
• Both gender
• Age between 30 to 70
• Medically stable
• No balance disorders before this stroke.
• History of mental
• illness or severe cognitive impairment (MINI-MENTAL SCALE SCORE > 25)

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Exclusion Criteria

• Stroke Patient with complication like shoulder hand syndrome, adhesive capsulitis or shoulder partial dislocation
• Stroke patients with behavioral issue, significant cognitive deficit
• Patients with arthritis and fracture
• Chronic stroke with deformities
• Serious viscera dysfunction, such as cardiovascular system,
• Lung, liver and kidney
• History of mental
• Illness or severe cognitive impairment (MINI-MENTAL SCALE SCORE > 25)
• Audio-visual understanding
• obstacle, unable to cooperate with instructions;
• Infection and ulcer skin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Universal Exercise Unit Therapy (UEU)	Universal Exercise Unit Therapy (UEU)	This experimental group will be given universal exercise unit therapy.
Group B: Sling Exercise Therapy (SET)	Sling Exercise Therapt (SET)	This experimental group will be given sling exercise therapy
Group C: Control Group	Routine Physical Therapy / Control Group	Control group will be given routine physical therapy

Primary Outcome Measures

Name	Time	Method
SHORT FORM 12 (SF-12): (QUALITY OF LIFE)	2 months	This survey contains 12 items divided into eight domains: physical function (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), role-emotional (RE), and mental health (MH). According to the calculation formula, raw scores were converted into final scores. As scores increased, health status and quality of life increased for the subject.
SMART PHONE MOTION ANALYSIS FOR LOWER LIMB KINEMATICS DURING WALKING	2 months	Sagittal plane hip, knee, and ankle angle and rear foot eversion will be assessed by using the Coach's Eye Smart phone application
BARTHEL INDEX: (FUNCTIONAL ABILITY)	2 months	This index is used to measure the activities of daily life, having total 10 items and can be scored from 0 to 100.
THE BERG BALANCE SCALE: (BALANCE FUNCTION)	2 months	This scale will be used to check the balance of the patients during the functional activities. Scale consists of 14 tasks and each task can be scored between 0 and 4. Overall balance score ranges from 0 to 56. 0 score is showing severely damage balance and 56 score is showing excellent balance. A score below 40 indicate the risk of falling in particular function.
FUNCTIONAL REACH TEST	2months	Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. In standing, measures the distance between the lengths of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.
TRUNK IMPAIRMENT SCALE	2 Months	The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.

Trial Locations

Locations (1)

Riphah Rehabilitation Center; 🇵🇰 Lahore, Punjab, Pakistan