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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05033873
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
17.5
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Universal Exercise Unit Therapy (UEU)
  • Other: Sling Exercise Therapt (SET)
  • Other: Routine Physical Therapy / Control Group
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Universal Exercise Unit Therapy With Sling Exercise Therapy on Lower Limb Kinematics in Chronic Stroke Patients
Actual Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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)
    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. 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). 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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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

    5. 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.

    6. TRUNK IMPAIRMENT SCALE [2 Months]

      The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Riphah Rehabilitation Center Lahore Punjab Pakistan

    Sponsors and Collaborators

    • Riphah International University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT05033873
    Other Study ID Numbers:
    • REC/RCR&AHS/21/1108
    First Posted:
    Sep 5, 2021
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riphah International University
    Motion analysis
    Universal exercise unit
    Sling exercise therapy
    Stroke
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Sep 5, 2021