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Completed

NCT Number: NCT03689764

Video Game-based Exercise for 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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical university Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

interactive video game-based exercise

Other

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 intervention

Other

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.

Primary outcomes

  1. Change of Berg Balance Scale (BBS)

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

    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.

Secondary outcomes

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

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

    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 .

  2. Change of Modified Falls Efficacy Scale (MFES)

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

    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.

  3. Change of Multidirectional Reach Test (MDRT)

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

    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.

  4. Change of Maximum Step Length (MSL) test

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

    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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Sep 28, 2018
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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