- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05490784
Effects of Lee Silverman Voice Treatment BIG on Dynamic Balance in Parkinson's Patients
November 8, 2022 updated by: Riphah International University
To determine the effects of Lee Silverman Voice Treatment BIG on dynamic balance in Parkinson's patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fedral
-
Islamabad, Fedral, Pakistan, 44000
- Riphah International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Lee Silverman Voice Treatment big with conventional treatment
|
Patients assigned to experimental group will get Lee Silverman Voice Treatment BIG along with conventional treatment.
|
|
ACTIVE_COMPARATOR: control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Gait Index
Time Frame: 9 months
|
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.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. 2022 Jan 18:1-8. doi: 10.1080/09593985.2022.2028325. Online ahead of print.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2022
Primary Completion (ACTUAL)
August 20, 2022
Study Completion (ACTUAL)
August 20, 2022
Study Registration Dates
First Submitted
August 4, 2022
First Submitted That Met QC Criteria
August 4, 2022
First Posted (ACTUAL)
August 8, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/21/0253
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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