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

NCT05033873 | Unknown

• 1 other identifier: REC/RCR&AHS/21/1108
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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.

  2 months

• 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.

  2 months

• 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.

  2 months

• 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

  2 months

• 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.

  2months

• TRUNK IMPAIRMENT SCALE

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

  2 Months

Study Arms (3)

Group A: Universal Exercise Unit Therapy (UEU)

EXPERIMENTAL

This experimental group will be given universal exercise unit therapy.

Other: Universal Exercise Unit Therapy (UEU)

Group B: Sling Exercise Therapy (SET)

EXPERIMENTAL

This experimental group will be given sling exercise therapy

Other: Sling Exercise Therapt (SET)

Group C: Control Group

OTHER

Control group will be given routine physical therapy

Other: Routine Physical Therapy / Control Group

Interventions

Universal Exercise Unit Therapy (UEU) 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.

Also known as: Group A

Group A: Universal Exercise Unit Therapy (UEU)

Sling Exercise Therapt (SET) 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

Also known as: Group B

Group B: Sling Exercise Therapy (SET)

Routine Physical Therapy / Control Group 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

Also known as: Group C

Group C: Control Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (10)

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

  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.

  PMID: 20130351 BACKGROUND

• 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.

  PMID: 33235553 BACKGROUND

• 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.

  PMID: 31910820 BACKGROUND

• 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.

  PMID: 29265018 BACKGROUND

• 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.

  PMID: 29037005 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rabiya Noor, PhD

  Riphah International University

  STUDY CHAIR

Central Study Contacts

Rabiya Noor, PhD

CONTACT

03344355660; rabiya.noor@riphah.edu.pk

Muhammad Salman Bashir, PhD

CONTACT

03334497959; salman.bashir@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: September 5, 2021
• Study Start: July 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)