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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689764
• Other study ID #: 201311032
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: January 15, 2019

Study information

• Verified date: October 2019
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 15, 2019
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• interactive video game-based exercise
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
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical university Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 .	15 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Secondary	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.	10 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Secondary	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.	10 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Secondary	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.	10 minutes/session; measured at weeks 0, 6, and 12 of the experiment