NCT03689764

Brief Summary

This study assessed the effects of interactive video game-based exercise (IVGB) on balance in persons with Parkinson's disease . Twenty-four patients were randomly allocated to two groups (12 participants per group). Group A underwent IVGB training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then received IVGB training in the subsequent 6 weeks. Both subjective and objective measures were used to determine whether IVGB exercise improves balance function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2014

Longer than P75 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

June 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

3.3 years

First QC Date

September 24, 2018

Last Update Submit

October 17, 2019

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Change of Berg Balance Scale (BBS)

    Participants perform a series of 14 functional balance tasks, such as maintaining a quiet stance, sitting-to-stand, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. The performance of each task is scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56 . Previous studies have shown that inter-rater and intra-rater reliability of BBS is high in elderly people and stroke patients.

    15 minutes/session; measured at weeks 0, 6, and 12 of the experiment

Secondary Outcomes (4)

  • Change of 36-Item Short-Form Health Survey (SF-36)

    15 minutes/session; measured at weeks 0, 6, and 12 of the experiment

  • Change of Modified Falls Efficacy Scale (MFES)

    10 minutes/session; measured at weeks 0, 6, and 12 of the experiment

  • Change of Multidirectional Reach Test (MDRT)

    10 minutes/session; measured at weeks 0, 6, and 12 of the experiment

  • Change of Maximum Step Length (MSL) test

    10 minutes/session; measured at weeks 0, 6, and 12 of the experiment

Study Arms (2)

Group A

EXPERIMENTAL

Group A underwent interactive video game-based exercise for the initial 6 weeks, with no treatment in the subsequent 6 weeks. The exercise program consisted of 30-minute sessions 3 times per week for 6 weeks. Outcomes were measured at weeks 0, 6, and 12.

Other: interactive video game-based exerciseOther: no intervention

Group B

EXPERIMENTAL

Group B had no intervention in the first 6 weeks and then received interactive video game-based exercise in the subsequent 6 weeks. The exercise program consisted of 30-minute sessions 3 times per week for 6 weeks. Outcomes were measured at weeks 0, 6, and 12.

Other: interactive video game-based exerciseOther: no intervention

Interventions

interactive video game-based exerciseOTHER

Twenty-four patients were randomly allocated to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no intervention in the subsequent 6 weeks. Group B had no intervention for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.

Group AGroup B
no interventionOTHER

Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no intervention in the subsequent 6 weeks. Group B had no intervention for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.

Group AGroup B

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medical diagnosis of idiopathic Parkinson's Disease
  • independent community ambulatory individuals
  • capable of giving informed and written consent (Mini-Mental Status Examination (MMSE)\>23)

You may not qualify if:

  • the other neurological conditions such as dementia, and stroke, or if they have arthritis, vision impairment,
  • cardiovascular disease that impair walking, or diabetic and uremic individuals, or if they were unable to walk without assistance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical university Hospital

Taipei, Taiwan

Location

Related Publications (3)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

    PMID: 38588457DERIVED

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

    PMID: 36602886DERIVED

  • Yuan RY, Chen SC, Peng CW, Lin YN, Chang YT, Lai CH. Effects of interactive video-game-based exercise on balance in older adults with mild-to-moderate Parkinson's disease. J Neuroeng Rehabil. 2020 Jul 13;17(1):91. doi: 10.1186/s12984-020-00725-y.

    PMID: 32660512DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Chien-Hung Lai, MD PhD

    Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 28, 2018

Study Start

June 1, 2014

Primary Completion

October 1, 2017

Study Completion

January 15, 2019

Last Updated

October 18, 2019

Record last verified: 2019-10

Locations

TW(1)