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Clinical Trials/NCT06459349
NCT06459349CompletedNot Applicable

Effects of Exteroceptive and Proprioceptive Sensory Stimulation Versus Sensorimotor Therapy on Spasticity, Motor Function and Activities of Daily Living in Patients With Stroke

Riphah International University2 sites in 1 country42 target enrollmentStarted: April 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
2
Primary Endpoint
Modified Barthel Index:

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Modified Barthel Index:

Time Frame: 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

Time Frame: 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

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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