Clinical trial NCT05033873: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stroke
Keywords: Motion analysis
Universal exercise unit
Sling exercise therapy
Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: THE BERG BALANCE SCALE: (BALANCE FUNCTION)
timeFrame: 2 months
measure: BARTHEL INDEX: (FUNCTIONAL ABILITY)
timeFrame: 2 months
measure: SHORT FORM 12 (SF-12): (QUALITY OF LIFE)
timeFrame: 2 months
measure: SMART PHONE MOTION ANALYSIS FOR LOWER LIMB KINEMATICS DURING WALKING
timeFrame: 2 months
measure: FUNCTIONAL REACH TEST
timeFrame: 2months
measure: TRUNK IMPAIRMENT SCALE
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Rabiya Noor, PhD
role: STUDY_CHAIR
References:
citation: Rajkumar S, Chandra SB. Recent advances in treatment of cerebral ischemic stroke. Medicine. 2021;10(1):1.
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.
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.
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.
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.
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.
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.
citation: Wooten A. Universal Exercise Unit for Treatment of a Child Following Hemispherectomy: A Case Report. 2017.
citation: Salim ASM. Effect of universal exercise unit on standing in spastic diaplegia. 2013.
citation: Olama KA, Elnahhas AM, Rajab SH. Effect of universal exercise unit on balance in children with spastic Diplegia.