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

U

University of Lahore

Status

Enrolling

Conditions

Parkinson Disease

Treatments

Other: Routine physical therapy
Other: General coordination exercise
Other: Sensory integration training

Study type

Interventional

Funder types

Other

Identifiers

NCT05907148
REC-UOL-367-04-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

46 participants in 2 patient groups

Routine Physical therapy along with Coordination exercises
Active Comparator group
Description:
The Control group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally will receive 30-minute general balance training. Active joint mobilization will be carried out with the patient in the supine, prone (if possible), or sitting positions. Muscle stretching will be carried out mainly in the supine, prone (if possible), and standing positions. Motor coordination exercises will be carried out in a supine position, sitting and standing positions.
Treatment:
Other: General coordination exercise
Other: Routine physical therapy
sensory Integration training group along with Routine physical therapy
Experimental group
Description:
experimental group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally 30 minutes of sensory integration therapy.
Treatment:
Other: Sensory integration training
Other: Routine physical therapy

Trial contacts and locations

2

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Central trial contact

Momna Asghar, MsPTN

Data sourced from clinicaltrials.gov

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