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Parkinson DiseaseNCT03689764

Video Game-based Exercise for Persons With Parkinson's Disease

A study testing interactive video game-based exercise in people with Parkinson Disease, run by Taipei Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
interactive video game-based exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteTaiwan
Study dates
Jun 2014to 15 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Medical university Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Effects of Interactive Video Game-based Exercise on Balance of Persons With Parkinson's Disease

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.

Read the detailed description

The experiments were conducted as a prospective, randomized, single blinded, crossover, 12-week trial. The group A undergoes the IVGB training in the initial 6 weeks (intervention phase), follows by suspended from exercise in the subsequent 6 weeks (control phase). The group B does not received treatment in the first 6 weeks (control phase), and then performs IVGB training in the following 6 weeks (intervention phase). For all participants, The 36-Item Short-Form Health Survey (SF-36), Modified Falls Efficacy Scale (MFES), Berg Balance Scale (BBS), Multidirectional reach test (MDRT) and Maximum step length (MSL) test were assessed at weeks 0, 6, and 12 of the experiment.

Being tested
interactive video game-based exercise, no intervention
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT03689764
Study groupRoleWhat they receive
Group AExperimentalGroup 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.
Receives: Other: interactive video game-based exercise; Other: no intervention
Group BExperimentalGroup 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.
Receives: Other: interactive video game-based exercise; Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

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

    The 8 scales in SF 36 including Physical function (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social Function (SF), Role-Emotional (RE), Mental Health (MH) . Neuromuscular condition is one of the most frequently studied disease with use of SF-36 .

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

  2. Change of Modified Falls Efficacy Scale (MFES)

    The MFES is a 14-item rating scale questionnaire that contains the original 10-activity Falls Efficacy Scale and 4 additional activities. Items are rated from 0 (not confident at all) to 10 (completely confident), and the highest possible score is 140.

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

  3. Change of Multidirectional Reach Test (MDRT)

    The participants were required to reach in the forward, left and right directions. For the forward-reaching direction, the participants began by raising both arms to the shoulder level. They were then instructed to reach forward as far as they could without moving their feet, while maintaining the end-range position for 3 seconds. A soft measuring tape fixed to the wall was used to measure the start and end positions of the middle finger to measure the reaching distance. The same instructions were provided for the lateral reaching tests, except that the participants lifted only their right or left arm when reaching in the right or left directions, respectively. Three trials were performed in each direction, and the reaching distance was normalized according to the measured foot length.

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

  4. Change of Maximum Step Length (MSL) test

    The participants performed the MSL test in the forward, lateral and backward directions. For the forward direction test, the participants assumed the starting position by crossing their arms over their chest. They were then instructed to take a maximum step forward with one leg without moving the other, and then to return to the starting position with a single step.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study startJun 2014
  3. Primary completionOct 2017
  4. Study completion15 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03689764
Sponsor's protocol ID
201311032
Status last verified
Oct 2019
First submitted
24 Sep 2018
Last updated
18 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38588457

  • 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.

    PubMed 36602886

  • 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.

    PubMed 32660512

Questions about this trial

What is this clinical trial studying?

A study testing interactive video game-based exercise in people with Parkinson Disease, run by Taipei Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Berg Balance Scale (BBS) (time frame: 15 minutes/session; measured at weeks 0, 6, and 12 of the experiment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03689764, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.

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