Clinical trial NCT06663657: Effects of Cognitive Versus Task Oriented Training on Balance, Gait and Daily Activity in Chronic Stroke Patients
Official title: Effects of Cognitive Sensorimotor Exercises Versus Task Oriented Training on Balance ,Gait and Activities of Daily Living in Chronic Stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Cognitive Impairment
Balance; Distorted
ADL
Keywords: Stroke, Ischemic
Cognitive Impairment
Balance; Distorted
ADL
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the patients will be randomized by lottery method and allocated into two intervention groups. Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. Patients in group B will receive task-oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. Intervention will be applied for 8 weeks it include taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks
Primary purpose: TREATMENT

Brief summary: To determine effects of cognitive sensorimotor exercises versus task oriented training on balance, gait and activities of daily living in chronic stroke patients.

Detailed description: This study will be randomized clinical trial with total of 40 participants with chronic stroke. Patients will be recruited from Riphah rehabilitation centre and National Hospital Lahore. The sampling technique will be non probability convenience sampling technique. The patients will be randomized by lottery method and allocated into two intervention groups.

Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. Patients in group B will receive task-oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. Intervention will be applied for 8 weeks it includes taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks. The assessment tools used will be berg balance test for balance, Dynamic gait index for gait and Modified Barthel index to assess activities of daily livings. Data will be analysed by using SPSS 25 version.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chronic stroke (6 months to 2 years)
* Patients with the ability to walk independently using aids or orthotics with or without supervision.
* Ability to communicate and follow instructions.
* No problem walking due to ankle contracture.
* No sensory deficiencies of the lower extremities.
* Patients cognition level on MMSE ≥ 24

Exclusion Criteria:

* Recent injuries- Patients having musculoskeletal or surgical problems of lower extremity.
* Co-morbid conditions- Cardiovascular (uncontrolled high blood pressure, diabetes), respiratory problems like dyspnoea.
* Neurological conditions- like brain tumour, demyelinating disease, Parkinson's disease, multiple sclerosis).
* Subjects with auditory and vestibular disorders.
* Cerebellar related problems.

Primary outcomes:
measure: The BBS (Berg Balance Scale)
timeFrame: 10 months
measure: The DGI (Dynamic Gait Index)
timeFrame: 10 months
measure: The Modified Barthel Index
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Ripah Internationa University
state: Fedral
Study officials:
affiliation: Riphah International University
name: zeest Z hashmi, MSNMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KH, Jang SH. Effects of Cognitive Sensory Motor Training on Lower Extremity Muscle Strength and Balance in Post Stroke Patients: A Randomized Controlled Study. Clin Pract. 2021 Sep 14;11(3):640-649. doi: 10.3390/clinpract11030079.
citation: Sutcu G, Ozcakar L, Yalcin AI, Kilinc M. BOBATH vs. TASK-ORIENTED TRAINING AFTER STROKE: An assessor-blind randomized controlled trial. Brain Inj. 2023 Jun 7;37(7):581-587. doi: 10.1080/02699052.2023.2203519. Epub 2023 Apr 19.
citation: Ghrouz A, Guillen-Sola A, Morgado-Perez A, Munoz-Redondo E, Ramirez-Fuentes C, Curbelo Pena Y, Duarte E. The effect of a motor relearning on balance and postural control in patients after stroke: An open-label randomized controlled trial. Eur Stroke J. 2024 Jun;9(2):303-311. doi: 10.1177/23969873231220218. Epub 2023 Dec 29.