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

NCT ID: NCT05033873

Last Updated: 2022-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2023-12-30

Brief Summary

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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

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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

Conditions

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A: Universal Exercise Unit Therapy (UEU)

This experimental group will be given universal exercise unit therapy.

Group Type EXPERIMENTAL

Universal Exercise Unit Therapy (UEU)

Intervention Type OTHER

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.

Group B: Sling Exercise Therapy (SET)

This experimental group will be given sling exercise therapy

Group Type EXPERIMENTAL

Sling Exercise Therapt (SET)

Intervention Type OTHER

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

Group C: Control Group

Control group will be given routine physical therapy

Group Type OTHER

Routine Physical Therapy / Control Group

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Group A Group B Group C

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rabiya Noor, PhD

Role: STUDY_CHAIR

Riphah International University

Locations

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Riphah Rehabilitation Center

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Rabiya Noor, PhD

Role: CONTACT

03344355660

Muhammad Salman Bashir, PhD

Role: CONTACT

03334497959

Facility Contacts

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Rabiya Noor, PhD

Role: primary

References

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND
PMID: 20130351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33235553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31910820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29265018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29037005 (View on PubMed)

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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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REC/RCR&AHS/21/1108

Identifier Type: -

Identifier Source: org_study_id

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