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

NCT06459349 | Completed DMC

• 1 other identifier: REC/RCR & AHS/23/0282
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke, Ischemic; Proprioceptive Disorders; Sensory Defect

Keywords

Stroke, Ischemic; Proprioceptive Disorders; Sensory Defect

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment

  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

  6 months

• Modified Barthel Index:

  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.

  6 months

• The Modified Ashworth Scale

  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.

  6 months

Study Arms (2)

exteroceptive and proprioceptive sensory stimulation

EXPERIMENTAL

Patients in this group will receive exteroceptive and proprioceptive sensory stimulation

Other: exteroceptive and proprioceptive sensory stimulation training

sensorimotor therapy group

ACTIVE COMPARATOR

Patients in this group will receive sensorimotor therapy

Other: sensorimotor therapy group

Interventions

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

exteroceptive and proprioceptive sensory stimulation

sensorimotor therapy group OTHER

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

sensorimotor therapy group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 33030307 BACKGROUND

• 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.

  PMID: 31114472 BACKGROUND

• 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.

  PMID: 34684135 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Somatosensory Disorders

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeest hashmi, MSNMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 .

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: April 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)