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

Primary Purpose

Chronic Stroke

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Universal Exercise Unit Therapy (UEU)

Sling Exercise Therapt (SET)

Routine Physical Therapy / Control Group

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Motion analysis, Universal exercise unit, Sling exercise therapy, Stroke

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Riphah Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Group A: Universal Exercise Unit Therapy (UEU)

Group B: Sling Exercise Therapy (SET)

Group C: Control Group

Arm Description

This experimental group will be given universal exercise unit therapy.

This experimental group will be given sling exercise therapy

Control group will be given routine physical therapy

Outcomes

Primary Outcome Measures

THE BERG BALANCE SCALE: (BALANCE FUNCTION)

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.

BARTHEL INDEX: (FUNCTIONAL ABILITY)

This index is used to measure the activities of daily life, having total 10 items and can be scored from 0 to 100.

SHORT FORM 12 (SF-12): (QUALITY OF LIFE)

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

Sagittal plane hip, knee, and ankle angle and rear foot eversion will be assessed by using the Coach's Eye Smart phone application

FUNCTIONAL REACH TEST

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05033873

First Posted

June 26, 2021

Last Updated

December 7, 2022

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05033873

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 15, 2021 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Stroke

Keywords

Motion analysis, Universal exercise unit, Sling exercise therapy, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A: Universal Exercise Unit Therapy (UEU)

Arm Type

Experimental

Arm Description

This experimental group will be given universal exercise unit therapy.

Arm Title

Group B: Sling Exercise Therapy (SET)

Arm Type

Experimental

Arm Description

This experimental group will be given sling exercise therapy

Arm Title

Group C: Control Group

Arm Type

Other

Arm Description

Control group will be given routine physical therapy

Intervention Type

Other

Intervention Name(s)

Universal Exercise Unit Therapy (UEU)

Other Intervention Name(s)

Group A

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sling Exercise Therapt (SET)

Other Intervention Name(s)

Group B

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Routine Physical Therapy / Control Group

Other Intervention Name(s)

Group C

Intervention Description

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

Primary Outcome Measure Information:

Title

THE BERG BALANCE SCALE: (BALANCE FUNCTION)

Description

Time Frame

2 months

Title

BARTHEL INDEX: (FUNCTIONAL ABILITY)

Description

This index is used to measure the activities of daily life, having total 10 items and can be scored from 0 to 100.

Time Frame

2 months

Title

SHORT FORM 12 (SF-12): (QUALITY OF LIFE)

Description

Time Frame

2 months

Title

SMART PHONE MOTION ANALYSIS FOR LOWER LIMB KINEMATICS DURING WALKING

Description

Sagittal plane hip, knee, and ankle angle and rear foot eversion will be assessed by using the Coach's Eye Smart phone application

Time Frame

2 months

Title

FUNCTIONAL REACH TEST

Description

Time Frame

2months

Title

TRUNK IMPAIRMENT SCALE

Description

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

Time Frame

2 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rabiya Noor, PhD

Phone

03344355660

rabiya.noor@riphah.edu.pk

First Name & Middle Initial & Last Name or Official Title & Degree

Muhammad Salman Bashir, PhD

Phone

03334497959

salman.bashir@riphah.edu.pk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rabiya Noor, PhD

Organizational Affiliation

Riphah International University

Official's Role

Study Chair

Facility Information:

Facility Name

Riphah Rehabilitation Center

City

Lahore

State/Province

Punjab

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rabiya Noor, PhD

rabiya.noor@riphah.edu.pk

First Name & Middle Initial & Last Name & Degree

Farjad Afzal, PhD*

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

Rajkumar S, Chandra SB. Recent advances in treatment of cerebral ischemic stroke. Medicine. 2021;10(1):1.

Results Reference

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PubMed Identifier

20130351

Citation

Busl KM, Greer DM. Hypoxic-ischemic brain injury: pathophysiology, neuropathology and mechanisms. NeuroRehabilitation. 2010;26(1):5-13. doi: 10.3233/NRE-2010-0531.

Results Reference

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PubMed Identifier

33235553

Citation

Sherin A, Ul-Haq Z, Fazid S, Shah BH, Khattak MI, Nabi F. Prevalence of stroke in Pakistan: Findings from Khyber Pakhtunkhwa integrated population health survey (KP-IPHS) 2016-17. Pak J Med Sci. 2020 Nov-Dec;36(7):1435-1440. doi: 10.12669/pjms.36.7.2824.

Results Reference

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PubMed Identifier

31910820

Citation

Yi X, Luo H, Zhou J, Yu M, Chen X, Tan L, Wei W, Li J. Prevalence of stroke and stroke related risk factors: a population based cross sectional survey in southwestern China. BMC Neurol. 2020 Jan 7;20(1):5. doi: 10.1186/s12883-019-1592-z.

Results Reference

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PubMed Identifier

29265018

Citation

Kamalakannan S, Gudlavalleti ASV, Gudlavalleti VSM, Goenka S, Kuper H. Incidence & prevalence of stroke in India: A systematic review. Indian J Med Res. 2017 Aug;146(2):175-185. doi: 10.4103/ijmr.IJMR_516_15.

Results Reference

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PubMed Identifier

29037005

Citation

Venketasubramanian N, Yoon BW, Pandian J, Navarro JC. Stroke Epidemiology in South, East, and South-East Asia: A Review. J Stroke. 2017 Sep;19(3):286-294. doi: 10.5853/jos.2017.00234. Epub 2017 Sep 29. Erratum In: J Stroke. 2018 Jan;20(1):142.

Results Reference

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Citation

Hussein ZA. Strength training versus chest physical therapy on pulmonary functions in children with Down syndrome. Egyptian Journal of Medical Human Genetics. 2017;18(1):35-9.

Results Reference

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Citation

Wooten A. Universal Exercise Unit for Treatment of a Child Following Hemispherectomy: A Case Report. 2017.

Results Reference

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Citation

Salim ASM. Effect of universal exercise unit on standing in spastic diaplegia. 2013.

Results Reference

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Citation

Olama KA, Elnahhas AM, Rajab SH. Effect of universal exercise unit on balance in children with spastic Diplegia.

Results Reference

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

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