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Effects of Lee Silverman Voice Treatment BIG on Dynamic Balance in Parkinson's Patients

Primary Purpose

Parkinson Disease, Motor Disorders, Balance; Distorted

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Lee Silverman Voice Treatment BIG
conventional treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Balance; Distorted, Motor Disorders

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stage I, II, III Parkinson's patients on Hoehn &;Yahr classification
  • Able to walk without assistive devices
  • Stable medication 4 weeks prior to and during study

Exclusion Criteria:

  • Patients with depression or dementia
  • Disabling bradykinesia to make sure patients are efficient to engage and cooperate in conventional physical therapy

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lee Silverman Voice Treatment big with conventional treatment

control group

Arm Description

Lee Silverman Voice Treatment big with conventional treatment

Patients assigned to control group received conventional treatment program encompassing set of exercises such as complex motor sequences, stretching, dual tasking, mental imagery and core stability.

Outcomes

Primary Outcome Measures

Dynamic Gait Index
Dynamic gait index assesses postural stability, gait, and balance. It evaluates various gait- related tasks with challenging situations such as head turn, speed change, obstacles and stairs climbing.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2022
Last Updated
November 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05490784
Brief Title
Effects of Lee Silverman Voice Treatment BIG on Dynamic Balance in Parkinson's Patients
Official Title
Effects of Lee Silverman Voice Treatment BIG on Dynamic Balance in Parkinson's Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
To determine the effects of Lee Silverman Voice Treatment BIG on dynamic balance in Parkinson's patients
Detailed Description
This study will be conducted to compare the effects of Lee Silverman Voice Treatment BIG and conventional physiotherapy on dynamic balance in patients of PD. Patients will be recruited according to inclusion criteria and data will be collected from Riphah rehabilitation center, National Hospital Lahore. Dynamic gait index will be used as data collection tool to test dynamic balance of patients. Patients will be allocated to intervention groups by randomization. After approval from ethical committee, data collection will be started and informed consent will be taken from all patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Motor Disorders, Balance; Distorted
Keywords
Parkinson Disease, Balance; Distorted, Motor Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
total 26 participants will be randomly assigned to experimental group (Lee Silverman Voice Treatment BIG along with conventional therapy) and control group( conventional treatment)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lee Silverman Voice Treatment big with conventional treatment
Arm Type
Experimental
Arm Description
Lee Silverman Voice Treatment big with conventional treatment
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients assigned to control group received conventional treatment program encompassing set of exercises such as complex motor sequences, stretching, dual tasking, mental imagery and core stability.
Intervention Type
Other
Intervention Name(s)
Lee Silverman Voice Treatment BIG
Intervention Description
Patients assigned to experimental group will get Lee Silverman Voice Treatment BIG along with conventional treatment.
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
patients in this group will get conventional treatment program encompassing set of exercises such as complex motor sequences, stretching, dual tasking, mental imagery and core stability.
Primary Outcome Measure Information:
Title
Dynamic Gait Index
Description
Dynamic gait index assesses postural stability, gait, and balance. It evaluates various gait- related tasks with challenging situations such as head turn, speed change, obstacles and stairs climbing.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage I, II, III Parkinson's patients on Hoehn &;Yahr classification Able to walk without assistive devices Stable medication 4 weeks prior to and during study Exclusion Criteria: Patients with depression or dementia Disabling bradykinesia to make sure patients are efficient to engage and cooperate in conventional physical therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeest hashmi, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35042438
Citation
Oguz S, Erturk G, Polat MG, Apaydin H. The effect of kinesiophobia on physical activity, balance, and fear of falling in patients with Parkinson's disease. Physiother Theory Pract. 2023 Apr;39(4):865-872. doi: 10.1080/09593985.2022.2028325. Epub 2022 Jan 18.
Results Reference
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PubMed Identifier
33969801
Citation
Fleming Walsh S, Balster C, Chandler A, Brown J, Boehler M, O'Rear S. LSVT BIG(R) and long-term retention of functional gains in individuals with Parkinson's disease. Physiother Theory Pract. 2022 May;38(5):629-636. doi: 10.1080/09593985.2020.1780655. Epub 2020 Jun 17.
Results Reference
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PubMed Identifier
33680093
Citation
Schaible F, Maier F, Buchwitz TM, Schwartz F, Hoock M, Schonau E, Libuda M, Hordt A, van Eimeren T, Timmermann L, Eggers C. Effects of Lee Silverman Voice Treatment BIG and conventional physiotherapy on non-motor and motor symptoms in Parkinson's disease: a randomized controlled study comparing three exercise models. Ther Adv Neurol Disord. 2021 Feb 18;14:1756286420986744. doi: 10.1177/1756286420986744. eCollection 2021.
Results Reference
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PubMed Identifier
32980872
Citation
Tremblay C, Abbasi N, Zeighami Y, Yau Y, Dadar M, Rahayel S, Dagher A. Sex effects on brain structure in de novo Parkinson's disease: a multimodal neuroimaging study. Brain. 2020 Oct 1;143(10):3052-3066. doi: 10.1093/brain/awaa234.
Results Reference
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Effects of Lee Silverman Voice Treatment BIG on Dynamic Balance in Parkinson's Patients

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