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

Not Applicable
Recruiting
Conditions
Parkinson Disease
Interventions
Other: Sensory integration training
Other: Routine physical therapy
Other: General coordination exercise
Registration Number
NCT05907148
Lead Sponsor
University of Lahore
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
46
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
sensory Integration training group along with Routine physical therapyRoutine physical therapyexperimental group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally 30 minutes of sensory integration therapy.
sensory Integration training group along with Routine physical therapySensory integration trainingexperimental group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally 30 minutes of sensory integration therapy.
Routine Physical therapy along with Coordination exercisesRoutine physical therapyThe 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.
Routine Physical therapy along with Coordination exercisesGeneral coordination exerciseThe 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.
Primary Outcome Measures
NameTimeMethod
Activities-specific Balance Confidence Scale (ABC):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):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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

the Univerity of Lahore Teaching hospital

🇵🇰

Lahore, Punjab, Pakistan

ganga Raam Hopital

🇵🇰

Lahore, Punjab, Pakistan

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