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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sensory integration training
Routine physical therapy
General coordination exercise
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Sensory Integration Training, Berg Balance Scale, Balance, Activities-Specific Balance Confidence Scale

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • ganga Raam HopitalRecruiting
  • the Univerity of Lahore Teaching hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Routine Physical therapy along with Coordination exercises

sensory Integration training group along with Routine physical therapy

Arm 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.

experimental group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally 30 minutes of sensory integration therapy.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2023
Last Updated
July 15, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05907148
Brief Title
Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease
Official Title
Effects of Sensory Integration Training on Balance and Confidence in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Sensory Integration Training, Berg Balance Scale, Balance, Activities-Specific Balance Confidence Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine Physical therapy along with Coordination exercises
Arm Type
Active Comparator
Arm 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.
Arm Title
sensory Integration training group along with Routine physical therapy
Arm Type
Experimental
Arm Description
experimental group training will consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally 30 minutes of sensory integration therapy.
Intervention Type
Other
Intervention Name(s)
Sensory integration training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine physical therapy
Other Intervention Name(s)
consist of active joint mobilization, muscle stretching, motor coordination exercises and additionally will receive 30-minute general balance training.
Intervention Description
It consist of active joint mobilization, muscle stretching, motor coordination exercises and general balance training
Intervention Type
Other
Intervention Name(s)
General coordination exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Berg Balance Scale (BBS):
Description
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
Time Frame
the change in the ability to balance in individual at baseline, 6th and 12th week
Title
Activities-specific Balance Confidence Scale (ABC):
Description
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.
Time Frame
the change in the ability to balance in individual at baseline, 6th and 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Momna Asghar, MsPTN
Phone
+92336249488
Email
momna2april@gnmail.com
Facility Information:
Facility Name
ganga Raam Hopital
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arooj Munawar, PHD
Email
arooj.munawar@uipt.uol.edu.pk
First Name & Middle Initial & Last Name & Degree
Abdul Majid shahid
Facility Name
the Univerity of Lahore Teaching hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
momna asghar, mspt
Phone
+923047487795
Email
momna2april@gmail.com
First Name & Middle Initial & Last Name & Degree
Abdul Majid shahid, DPT

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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