Clinical trial NCT06459349: Effects of Sensory Stimulation Versus Sensorimotor Therapy on Spasticity, Motor Function and Daily Activities in Stroke
Official title: Effects of Exteroceptive and Proprioceptive Sensory Stimulation Versus Sensorimotor Therapy on Spasticity, Motor Function and Activities of Daily Living in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Proprioceptive Disorders
Sensory Defect
Keywords: Stroke, Ischemic
Proprioceptive Disorders
Sensory Defect
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be divided to group A (n=21) which will receive intervention exteroceptive and proprioceptive sensory stimulation and to group B (n=21) which will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks .
Primary purpose: TREATMENT

Brief summary: To compare effects of exteroceptive and proprioceptive sensory stimulation versus sensorimotor therapy on spasticity, motor function and activities of daily living in patients with stroke

Detailed description: It will be a randomized clinical trial in which total 42 stroke patients will be recruited through non probability convenience sampling techniques. Data will be collected from Gujranwala Medical College Teaching Hospital and Riphah Rehabilitation Center Lahore. The patients who are fulfilling the inclusion criteria will be randomly assigned to either group A (n=21) which will receive intervention exteroceptive and proprioceptive sensory stimulation or to group B (n=21) which will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks. Baseline treatment will be given to both groups. Conventional therapy will be given for 20 minutes per session, 03 times a week, for 06 weeks. Data collection tools will be Fugl-Meyer Assessment, Modified Barthel Index and Modified Ashworth Scale.

Eligibility criteria: Inclusion Criteria:

* The patients with chronic stroke (6 months to 2 years)
* Patient 's muscular activity on Stage 3 or higher according to the Brunnstrom's stages of stroke recovery.
* Patients having Mini Mental State Examination score \> 24

Exclusion Criteria:

* Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
* Any other neurological disorders like multiple sclerosis, Parkinson 's disease.
* History of orthopaedic surgery.
* Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
* Severe visual or vestibular impairments.
* Lower limb prosthesis.

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: 6 months
measure: Modified Barthel Index:
timeFrame: 6 months
measure: The Modified Ashworth Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Fedral
Study officials:
affiliation: Riphah International University
name: Zeest hashmi, MSNMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zlokovic BV, Gottesman RF, Bernstein KE, Seshadri S, McKee A, Snyder H, Greenberg SM, Yaffe K, Schaffer CB, Yuan C, Hughes TM, Daemen MJ, Williamson JD, Gonzalez HM, Schneider J, Wellington CL, Katusic ZS, Stoeckel L, Koenig JI, Corriveau RA, Fine L, Galis ZS, Reis J, Wright JD, Chen J. Vascular contributions to cognitive impairment and dementia (VCID): A report from the 2018 National Heart, Lung, and Blood Institute and National Institute of Neurological Disorders and Stroke Workshop. Alzheimers Dement. 2020 Dec;16(12):1714-1733. doi: 10.1002/alz.12157. Epub 2020 Oct 8.
citation: Serrada I, Hordacre B, Hillier SL. Does Sensory Retraining Improve Sensation and Sensorimotor Function Following Stroke: A Systematic Review and Meta-Analysis. Front Neurosci. 2019 Apr 30;13:402. doi: 10.3389/fnins.2019.00402. eCollection 2019.
citation: Kim KH, Jang SH. Effects of Task-Specific Training after Cognitive Sensorimotor Exercise on Proprioception, Spasticity, and Gait Speed in Stroke Patients: A Randomized Controlled Study. Medicina (Kaunas). 2021 Oct 13;57(10):1098. doi: 10.3390/medicina57101098.