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NCT Number: NCT06459349

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

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

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Proprioceptive Disorders Sensation Disorders Sensory Defect Signs and Symptoms Somatosensory Disorders Stroke Vascular Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Islamabad, Fedral, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exteroceptive and proprioceptive sensory stimulation training

Other

Patients in this group will receive intervention exteroceptive and proprioceptive sensory stimulation for 50 minutes per session, 03 times a week, for 06 weeks

sensorimotor therapy group

Other

Patients will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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