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

December 7, 2022 updated by: Riphah International University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Recruiting
        • Riphah Rehabilitation Center
        • Contact:
        • Principal Investigator:
          • Farjad Afzal, PhD*

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Universal Exercise Unit Therapy (UEU)
This experimental group will be given universal exercise unit therapy.
Other: Universal Exercise Unit Therapy (UEU)
Standing, walk standing, half standing, kneel standing, half kneel standing, quadruped position, three point quadruped , alternative quadruped , transitions, walking all these will be done in Universal Exercise Unit with a standardized protocol regimen.
Other Names:
  • Group A
Experimental: Group B: Sling Exercise Therapy (SET)
This experimental group will be given sling exercise therapy
Other: Sling Exercise Therapt (SET)
  1. The patient's bilateral knee joints/feet will be suspended by a rope belt, and then the patient's pelvis will be elevated and maintained in supine or lateral position, adding flexion and extension training to lower limb if permitted.
  2. In supine or lateral position, with patient's head, trunk and pelvis fixed, the therapist will use appropriate elastic bands to assist patient's limbs to do passive-power assisted-power resistance training in all directions (bending, stretch, outreach, and adduction).
  3. The patient's chest and abdomen will be suspended by a wide elastic band, positioned him-self in the prone position with the fulcrum of bilateral elbows and knees, and then the torso swayed in all directions, therapists could assist
  4. Target elbow and wrist will be suspended, according to the patient's ability to do passive/active open and close chain movement
Other Names:
  • Group B
Other: Group C: Control Group
Control group will be given routine physical therapy
Other: Routine Physical Therapy / Control Group

Control group will receive routine physiotherapy with duration one hour including

  • Active and passive joint movement
  • Muscle strength training
  • Bridging exercises
  • Balance training in sitting and standing positions, according to the patients' functional state.
  • Weight bearing exercises on affected Limbs
Other Names:
  • Group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
THE BERG BALANCE SCALE: (BALANCE FUNCTION)
Time Frame: 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.
2 months
BARTHEL INDEX: (FUNCTIONAL ABILITY)
Time Frame: 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.
2 months
SHORT FORM 12 (SF-12): (QUALITY OF LIFE)
Time Frame: 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.
2 months
SMART PHONE MOTION ANALYSIS FOR LOWER LIMB KINEMATICS DURING WALKING
Time Frame: 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
2 months
FUNCTIONAL REACH TEST
Time Frame: 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.
2months
TRUNK IMPAIRMENT SCALE
Time Frame: 2 Months
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
2 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Study Chair: Rabiya Noor, PhD, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

June 26, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/21/1108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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