Effects of Vestibular Rehabilitation on Balance and Post Stroke Fatigue :

NCT06673771 | Recruiting

• 1 other identifier: Zil-e-huma
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to determine the effects of stroke conventional therapy compared with the effects of vestibular rehabilitation therapy on balance and post stroke fatigue. The study will be randomized control trial including 2 experimental groups with estimated 28 individual in each group

Conditions

Stroke Patients

Keywords

conventional treatment; VRT Treatment; stroke population

Outcome Measures

Primary Outcomes (2)

• 1. Berg Balance Scale

  changes from the baseline, Berg balance scale (BBS) is used for assessment of balance and fall risk, Higher scores on the BBS indicate greater independence and better ability to balance. In contrast, lower scores indicate a greater fall risk Items DESCRIPTION SCORE (0-4) Sitting to standing, Standing unsupported, Sitting unsupported, Standing to sitting, Transfers , Standing with eyes closed , Standing with feet together, Reaching forward with outstretched arm, Retrieving object from floor, Turning to look behind, Turning 360 degrees, Placing alternate foot on stool, Standing with one foot in front, Standing on one foot, TOTAL \_\_/56

  8 weeks

• Fatigue Assessment Scale

  The FAS questionnaire was used to assess fatigue symptoms. This self-report questionnaire includes 10 items based on Likert's 5-point scale (1 = never, 5 = often). FAS scores vary from 10 to 50, with higher scores indicating increased fatigue. Fatigue in stroke patients was set at 24 based on the FAS. Total score range from 10 to 50. less than 22 indicates normal, 22 to 34 indicate mild to moderate fatigue,35 or more indicate severe fatigue.

  8 weeks

Study Arms (2)

Vestibular Rehabiliation Therapy

EXPERIMENTAL

VRT include head and body movemnt, eye movement, balance training

Other: Vestibular Rehabiliation Therapy

Conventional Treatment

ACTIVE COMPARATOR

conventional treatment include balance, walking, weight shifting and muscle strengthening training

Other: Conventional treatment

Interventions

Vestibular Rehabiliation Therapy OTHER

Moving the eye horizontally between two stationary target while keeping the head still Moving the eye vertically between two stationary target while keeping the head still Moving the target horizontally and tracking it with the eye while keeping the head still Moving the target vertically and tracking it with the eye while keeping the head still Moving the head horizontally while a keeping a look on stationary target Moving the head vertically while a keeping a look on stationary target Moving the head and target in opposite direction horizontally while tracking the target with eyes Moving the head and target in opposite direction vertically while tracking the target with eyes. Sit down and stand up, sit down and stand up with eye open and eye close Stand up, but turn to the right while standing Stand up, but turn to the left while standing Place an object on the floor. Take it and bring it above your head and place it on the floor again

Vestibular Rehabiliation Therapy

Conventional treatment OTHER

Standing balance training, weight shifting training, walking training, muscle strength training, step-up-and-down training.

Conventional Treatment

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with stroke.
• Ability to stand for at least 1 minute without support.
• Fatigue Assessment Scale (FAS) score ≥ 24.
• Willingness to participate

You may not qualify if:

• Cognitive Impairment.
• Severe unilateral spatial neglect.
• Severe aphasia.
• Patients who are not willing.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Helping Hand Institute of rehabilitation

Mānsehra, Khyber Pakhtunkhuwa, 2500, Pakistan

RECRUITING

Study Officials

• Nadia Azhar MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Azhar MS-NMPT

CONTACT

+923335281431; Nadia.azhar@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 5, 2024
• Study Start: November 1, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)