Effects of Sensory Stimulation Versus Sensorimotor Therapy on Spasticity, Motor Function and Daily Activities in Stroke

Not Applicable

Completed

• Conditions: Proprioceptive Disorders; Sensory Defect; Stroke, Ischemic
• Interventions: Other: exteroceptive and proprioceptive sensory stimulation training; Other: sensorimotor therapy group

• Registration Number: NCT06459349
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-14
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exteroceptive and proprioceptive sensory stimulation	exteroceptive and proprioceptive sensory stimulation training	Patients in this group will receive exteroceptive and proprioceptive sensory stimulation
sensorimotor therapy group	sensorimotor therapy group	Patients in this group will receive sensorimotor therapy

Primary Outcome Measures

Name	Time	Method
Modified Barthel Index:	6 months	Modified Barthel Index: It assesses the level of ability to perform daily activities. This questionnaire measures one's ability to perform different aspects of daily performance on a 0 to 100 scale, with higher scores indicating better performance. 0 to 20 scores are considered as complete dependency, 20 to 60 grades as severe dependency, 61 to 90 as moderate dependency, 91 to 99 as partial dependency and 100 as complete independence.
The Modified Ashworth Scale	6 months	The Modified Ashworth Scale is used to assess muscle spasticity. Spasticity using this scale, is the amount of muscle tone that scores between 0 and 4. Score 0 means no increase in tone; score; 1 slight increase in muscle tone, with little resistance at the end of the flexion range or extension of involved limb; +1 score slight increase in muscle tone, characterized by slightly resistance at less than half the flexion or extension of involved limb; score 2 significant increase in muscle tone in most limb range;, score 3 significant increase in passive muscle tone, movement is difficult; and score 4 limb involved in flexion or extension rigidity.
Fugl-Meyer Assessment	6 months	Fugl-Meyer Assessment: It is designed to evaluate functional recovery after stroke and is based on the poststroke recovery sequence. The test evaluates 5 domains of upper limb, lower limb, balance, sensation, and range of motion in 155 items. The overall reliability was high (overall intraclass correlation coefficient = .96), and the intraclass correlation coefficients for the subsections of the assessment varied from .61 for pain to .97 for the upper extremity. Greater scores refer to improvement in limb functions

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Islamabad, Fedral, Pakistan