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Clinical Trials/NCT05907148
NCT05907148
Recruiting
N/A

Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease

University of Lahore2 sites in 1 country46 target enrollmentNovember 25, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Lahore
Enrollment
46
Locations
2
Primary Endpoint
Activities-specific Balance Confidence Scale (ABC):
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The Objective of this research was to study the effectiveness of sensory integration training on balance and confidence in patients with Parkinson's disease.

Null Hypothesis:

Sensory integration training and conventional balance training have no significant difference in improving balance and confidence of patients with Parkinson's disease.

Alternative Hypothesis:

Sensory integration training and conventional balance training have a significant difference in improving balance and confidence in patients with Parkinson's disease.

Detailed Description

The study design will be randomized controlled clinical trial. Patients who fulfill the inclusion criteria will be identified by individual physiotherapist and will be enrolled for particular study. A sample size of 46 patients will be taken in this study by expecting a mean change 10.42 using 80% power of study and 95% level of significance and 20% dropout will also be included. So each group contains 23 participants. The study will be single blinded. The outcome assessor will be unaware of the treatment given to both groups. Sample will be collected through simple random sampling technique, and randomization sequencing will be generated with help of lottery. After selection the sample patients will be divided into two groups, allocation concealment will be ensured by using sealed envelopes. Group A will be given conventional balance training along with routine physical therapy without sensory integration and Group B will be given sensory integration physical therapy along with routine physical therapy. Group A will be called control group and Group B will be called experimental group. Every patient has to pick up an envelope which will be placed in patient's file which later will be opened by the researcher who will provide patient treatment accordingly.

Registry
clinicaltrials.gov
Start Date
November 25, 2022
End Date
October 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Lahore
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male and female patients diagnosed by a neurologist with Parkinson's disease.
  • Patients having BBS score between 21-40
  • At least 6 months post neurological Sensory/Motor deficit patient.
  • Age between 30 -65 years.
  • Ability to maintain standing position without aids for at least 5 minutes.
  • Normal vision
  • No severe systemic disorders
  • An ability to understand and perform the test

Exclusion Criteria

  • Patients with other existing neuromuscular disorders or medical conditions that substantially influences their gait and balance performance
  • Neuropathy patients
  • Vestibular disorders, paroxysmal vertigo.
  • Presence of orthopedic conditions involving the lower limbs.
  • Patients with psychiatric disorders.
  • Pregnant patients.

Outcomes

Primary Outcomes

Activities-specific Balance Confidence Scale (ABC):

Time Frame: the change in the ability to balance in individual at baseline, 6th and 12th week

This validated and reliable self-reported measure evaluates the patient's perceived level of balance confidence in performing various ambulatory activities without falling or experiencing a sense of instability. The overall score is calculated by adding the item scores and then dividing by the total number of items (score range, 0-100 points per activity; higher=more confident.

Berg Balance Scale (BBS):

Time Frame: the change in the ability to balance in individual at baseline, 6th and 12th week

The BBS is a 14-item validated scale that assesses static and dynamic Balance disorders in individuals with Parkinson's disease (score range, 0-56; higher=better performance). The items explore the ability to sit, stand, lean, turn, and maintain the upright position on one leg. Performance of these tasks depends on central integration processes to select specific response strategies which, in turn, depend on the characteristics of external postural displacement and goals

Study Sites (2)

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