NCT05490784

Brief Summary

To determine the effects of Lee Silverman Voice Treatment BIG on dynamic balance in Parkinson's patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

August 4, 2022

Last Update Submit

November 8, 2022

Conditions

Parkinson DiseaseMotor DisordersBalance; Distorted

Keywords

Parkinson DiseaseBalance; DistortedMotor Disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 months

Study Arms (2)

Lee Silverman Voice Treatment big with conventional treatment

EXPERIMENTAL

Lee Silverman Voice Treatment big with conventional treatment

Other: Lee Silverman Voice Treatment BIG

control group

ACTIVE COMPARATOR

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.

Other: conventional treatment

Interventions

Lee Silverman Voice Treatment BIGOTHER

Patients assigned to experimental group will get Lee Silverman Voice Treatment BIG along with conventional treatment.

Lee Silverman Voice Treatment big with conventional treatment
conventional treatmentOTHER

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.

control group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 35042438BACKGROUND

  • 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.

    PMID: 33969801BACKGROUND

  • 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.

    PMID: 33680093BACKGROUND

  • 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.

    PMID: 32980872BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseMotor Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesMental Disorders

Study Officials

  • zeest hashmi, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: total 26 participants will be randomly assigned to experimental group (Lee Silverman Voice Treatment BIG along with conventional therapy) and control group( conventional treatment)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

January 1, 2022

Primary Completion

August 20, 2022

Study Completion

August 20, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)