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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Routine physical therapy; Other: General coordination exercise; Other: Sensory integration training

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Momna Asghar, MsPTN; Phone Number: +92336249488; Email: momna2april@gnmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Recruiting
      • ganga Raam Hopital
      • Contact: Arooj Munawar, PHD; Email: arooj.munawar@uipt.uol.edu.pk
      • Principal Investigator: Abdul Majid shahid
    • Lahore, Punjab, Pakistan
      • Recruiting
      • the Univerity of Lahore Teaching hospital
      • Contact: momna asghar, mspt; Phone Number: +923047487795; Email: momna2april@gmail.com
      • Principal Investigator: Abdul Majid shahid, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine Physical therapy along with Coordination exercises; 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.	Other: Routine physical therapy; It consist of active joint mobilization, muscle stretching, motor coordination exercises and general balance training; Other Names: consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally will receive 30-minute general balance training.; Other: General coordination exercise; In supine lying: Patients are told to place heel of one leg on shin or knee of the other leg,; Patient bends one leg and extends the other leg like bicycling motion.; Flexing one leg while extending other leg; Flexing and extending of one leg while abduction and adduction of other leg. In sitting: Patient performs marching without backrest or back support,; Patient reaches forward and sideways with arms; Rotation of trunk with physioball in hand without back support.; Patient reaches with legs to marked point in sitting. In standing: Patient performs 10 repetitions of; Clock Reach; Side Leg Raises; Leg Swings and; Ball catch and throw
Experimental: sensory Integration training group along with Routine physical therapy; experimental group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally 30 minutes of sensory integration therapy.	Other: Routine physical therapy; It consist of active joint mobilization, muscle stretching, motor coordination exercises and general balance training; Other Names: consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally will receive 30-minute general balance training.; Other: Sensory integration training; Sitting position: Sit in a chair without a backrest while the feet on firm surface. without backrest while the feet on soft surface.; Sit on a ball while the feet on firm surface. while feet on soft surface.; Sit in a chair without a backrest with the feet on firm surface and perform sit-to-stand motion.without a backrest with the feet on soft surface and perform sit-to-stand motion.; Sit on a ball with the feet on the firm surface and perform sit-to-stand motion. with the feet on the soft surface and perform sit-to-stand motion.; Perform bipedal standing on a firm surface. on a soft surface.; Perform a semi-tandem stance on firm surface. on soft surface.; Walk forward on firm surface. on soft surface.; Walk forward on firm surface, cross obstacle, and continue to walk.; Walk forward on the soft surface, cross obstacle, and continue to walk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (BBS):	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	the change in the ability to balance in individual at baseline, 6th and 12th week
Activities-specific Balance Confidence Scale (ABC):	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.	the change in the ability to balance in individual at baseline, 6th and 12th week

Collaborators and Investigators

• Sponsor: University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Balance; Parkinson Disease; Berg Balance Scale; Sensory Integration Training; Activities-Specific Balance Confidence Scale
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: REC-UOL-367-04-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No