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Clinical Trials/NCT05520541
NCT05520541
Completed
Not Applicable

Investigation of the Effects of Clinical Based LSVT-BIG Training and Home Based LSVT-BIG Training on Balance and Gait in Parkinson's Patients

Gazi University1 site in 1 country14 target enrollmentAugust 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Gazi University
Enrollment
14
Locations
1
Primary Endpoint
Static Balance- Baseline
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Parkinson's disease (PD) is a chronic, progressive disease that causes motor and non-motor symptoms due to dopaminergic neuron loss. Today, the treatment of PD in addition to optimal medical and surgical treatments, physiotherapy and rehabilitation approaches have an important place in the treatment. Recently, it has been stated that intensive rehabilitation interventions in the field of physiotherapy and rehabilitation can be more effective than traditional rehabilitation approaches. Lee Silverman VoiceTreatment- BIG (LSVT-BIG) is a high-intensity exercise model aimed at improving bradykinesia and hypokinesia in PD. There are many studies showing improvements in balance, walking, motor performance, reaching ability, postural control, quality of life and cognitive status after LSVT-BIG training in PD. However, it is seen that there is no study investigating the effect of LSVT-BIG training directly by applying it as a home program. For this reason, there is a need for studies investigating whether this intensive treatment method can be an alternative to the clinical environment by applying it as a home program.

Detailed Description

This study is planned as a randomized control trial. Patients will be randomly divided into two groups a clinical group and a home group. The clinical group will be received LSVT-BIG training four times a week for four weeks in the clinic. The home group will be received LSVT-BIG training two times a week for four weeks at the home and two times a week for four weeks at the clinical. All assessments will be done before and after the 4-week intervention program or waiting period. The demographic characteristics of the participants initially will be taken. The outcome measures are balance and gait assessments.

Registry
clinicaltrials.gov
Start Date
August 15, 2022
End Date
July 22, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sefa Eldemir

Principal Investigator

Gazi University

Eligibility Criteria

Inclusion Criteria

  • 18-80 years of age
  • Having diagnosed with "Parkinson's Disease" by a specialist physician
  • Having between 1-3 stages according to the Hoehn and Yahr Scale
  • Mini-Mental Test score more than or equal 24

Exclusion Criteria

  • Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results

Outcomes

Primary Outcomes

Static Balance- Baseline

Time Frame: Assessment will be conducted before the intervention.

Assessment will be made with the Biodex Balance System

Gait speed- Baseline

Time Frame: Assessment will be conducted before the intervention.

Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait

Gait speed- Post intervention

Time Frame: Assessment will be conducted immediately after the intervention.

Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait

Gait cadence- Baseline

Time Frame: Assessment will be conducted before the intervention.

Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait

Gait cadence- Post intervention

Time Frame: Assessment will be conducted immediately after the intervention.

Assessment will be made with the BTS G-WALK, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy;SN: 0213- 0378) during gait

Static Balance- Post intervention

Time Frame: Assessment will be conducted immediately after the intervention.

Assessment will be made with the Biodex Balance System

Study Sites (1)

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