The Effectiveness of LSVT-BIG Training in Improving Balance and Gait in Parkinson's Patients

NCT05520541 | Completed

• 1 other identifier: 3- PD-LSWT-Trainig
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; LSVT-BIG Training; Home Based Exercise; Balance; Walking

Outcome Measures

Primary Outcomes (6)

• Static Balance- Baseline

  Assessment will be made with the Biodex Balance System

  Assessment will be conducted before the intervention.

• Static Balance- Post intervention

  Assessment will be made with the Biodex Balance System

  Assessment will be conducted immediately after the intervention.

• Gait speed- Baseline

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

  Assessment will be conducted before the intervention.

• Gait speed- Post intervention

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

  Assessment will be conducted immediately after the intervention.

• Gait cadence- Baseline

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

  Assessment will be conducted before the intervention.

• Gait cadence- Post intervention

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

  Assessment will be conducted immediately after the intervention.

Study Arms (2)

Clinical Group

EXPERIMENTAL

This group will receive clinical-based LSVT-BIG training

Other: Exercise

Home Group

ACTIVE COMPARATOR

This group will receive home-based LSVT-BIG training

Other: Exercise

Interventions

Exercise OTHER

Both groups will receive exercise-based training

Clinical Group; Home Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• Millage B, Vesey E, Finkelstein M, Anheluk M. Effect on Gait Speed, Balance, Motor Symptom Rating, and Quality of Life in Those with Stage I Parkinson's Disease Utilizing LSVT BIG(R). Rehabil Res Pract. 2017;2017:9871070. doi: 10.1155/2017/9871070. Epub 2017 Feb 26.

  PMID: 28331638 RESULT

• Hirakawa Y, Takeda K, Koyama S, Naoi Y, Matsushita T, Nagai T, Motoya I, Sakurai H, Kanada Y, Kawamura N, Kawamura M, Tanabe S. Effect of Lee Silverman Voice Treatment (LSVT)(R) BIG on motor symptoms in a patient with severe Parkinson's disease: a case report. Physiother Theory Pract. 2022 Nov;38(13):3159-3168. doi: 10.1080/09593985.2021.1938304. Epub 2021 Jun 14.

  PMID: 34125001 RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Arzu Güçlü-Gündüz, PT, PhD.

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups as clinical group and home group

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 30, 2022
• Study Start: August 15, 2022
• Primary Completion: March 30, 2023
• Study Completion: July 22, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)