Back to resultsVideo Game Balance Training for Patients With Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathy Peripheral
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
interactive video game-based exercise
no exercise
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy Peripheral
Eligibility Criteria
Inclusion Criteria:
- 40-80 years of age
- medical diagnoses of diabetes under regular medication control and diabetic peripheral neuropathy confirmed using an electrodiagnostic test
- independent community ambulatory individuals
- intact cognition (Mini-Mental State Examination score of >24).
Exclusion Criteria:
- other neurological diseases such as dementia, Parkinson's disease, spinal cord injury, or stroke;
- severe visual impairment, musculoskeletal disorders, unhealed plantar ulceration, lower limb amputation, poor cardiopulmonary function, or other diseases affecting walking ability or any other disease due to which individuals were unable to walk without assistance
- any other condition associated with a high risk of falling.
- Inability to follow simple instructions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Group A received interactive video game-based exercise training for the first 6 weeks, with no 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.
Group B had no exercise in the first 6 weeks and then underwent interactive video game-based exercise training 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.
Outcomes
Primary Outcome Measures
Change of Berg Balance Scale (BBS) score
It consists of 14 functional tasks of varying difficulty, including sitting, standing, changing posture, transfers, reaching forward, retrieving objects, turning, tandem stance, and one-leg stance. It is a valid tool used in both clinical practice and research to evaluate the efficacy of intervention and provide a quantitative description of balance function. The ability to perform each a task is scored on a scale of 0-4, ranging from inability to independently perform the task to successfully completing it, respectively. The maximum possible score for the 14 functional tasks is 56.
Secondary Outcome Measures
Change of Time Up and Go (TUG) test time
Participants stand up from a 46-cm-high armchair with back support, walk straight for 3 m, turn around, walk back to the chair, and sit down as quickly and safely as possible. The timing starts when the investigator says "go" and stops when the participant sits back down on the chair. In our study, each participant had three chances to complete the TUG test in each session, and the best result was recorded for each participant.
Change of Modified Falls Efficacy Scale (MFES) scores
MFES is a 14-item questionnaire related to daily indoor and outdoor physical activities. It is a 10-point visual analog scale of confidence level in completing a particular activity (item) without falling, rated from 0 to 10, where 0 denotes not confident or sure at all, and 10 denotes completely confident or sure. The total score for the 14 items ranges from 0 to 140.
Change of Unipedal Stance Test (UST) time
Participants raised one leg to the ankle level or higher without touching the other leg or using any assistance and then stood on that leg for as long as possible barefoot and with eyes open. The observer measured the length of time for which participants maintained balance; that is, until they were no longer able to keep the leg raised at or above the ankle level or when both legs touched the ground. The observer stopped counting at 45 seconds, recording this as the time for any participant who maintained balance for a longer time. Each participant performed the test three times for both right and left legs, with the best result for each leg recorded.
Full Information
NCT ID
NCT03676595
First Posted
September 13, 2018
Last Updated
September 17, 2018
Sponsor
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03676595
Brief Title
Video Game Balance Training for Patients With Diabetic Neuropathy
Official Title
Effects of Interactive Video Game-Based Exercise on Balance in Diabetic Patients With Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 20, 2013 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluated the effects of interactive video game-based exercise (IVGB) on balance in diabetic patients with peripheral neuropathy. Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received 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 underwent IVGB training in the subsequent 6 weeks. Both subjective and objective measures were used to determine whether IVGB exercise improves balance function.
Detailed Description
Participants in Group A received IVGB intervention for the first 6 weeks (intervention phase), with no exercise in the subsequent 6 weeks (control phase), whereas participants in Group B received no IVGB intervention in the first 6 weeks (control phase), followed by 6 weeks of IVGB intervention (intervention phase). The IVGB intervention protocol consisted of 30-minute training sessions comprising four tasks designed to focus on lower limb strength, balance, and coordination training. Balance assessments consisted of both subjective and objective measures, including the Modified Falls Efficacy Scale (MFES), Time Up and Go (TUG) test, Berg Balance Scale (BBS), and Unipedal Stance Test (UST). For all participants, these tests were conducted at weeks 0, 6, and 12 of the experiment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy Peripheral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A received interactive video game-based exercise training for the first 6 weeks, with no 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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B had no exercise in the first 6 weeks and then underwent interactive video game-based exercise training 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.
Intervention Type
Other
Intervention Name(s)
interactive video game-based exercise
Intervention Description
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 exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
Intervention Type
Other
Intervention Name(s)
no exercise
Intervention Description
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 exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
Primary Outcome Measure Information:
Title
Change of Berg Balance Scale (BBS) score
Description
It consists of 14 functional tasks of varying difficulty, including sitting, standing, changing posture, transfers, reaching forward, retrieving objects, turning, tandem stance, and one-leg stance. It is a valid tool used in both clinical practice and research to evaluate the efficacy of intervention and provide a quantitative description of balance function. The ability to perform each a task is scored on a scale of 0-4, ranging from inability to independently perform the task to successfully completing it, respectively. The maximum possible score for the 14 functional tasks is 56.
Time Frame
15 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Secondary Outcome Measure Information:
Title
Change of Time Up and Go (TUG) test time
Description
Participants stand up from a 46-cm-high armchair with back support, walk straight for 3 m, turn around, walk back to the chair, and sit down as quickly and safely as possible. The timing starts when the investigator says "go" and stops when the participant sits back down on the chair. In our study, each participant had three chances to complete the TUG test in each session, and the best result was recorded for each participant.
Time Frame
5 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Title
Change of Modified Falls Efficacy Scale (MFES) scores
Description
MFES is a 14-item questionnaire related to daily indoor and outdoor physical activities. It is a 10-point visual analog scale of confidence level in completing a particular activity (item) without falling, rated from 0 to 10, where 0 denotes not confident or sure at all, and 10 denotes completely confident or sure. The total score for the 14 items ranges from 0 to 140.
Time Frame
10 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Title
Change of Unipedal Stance Test (UST) time
Description
Participants raised one leg to the ankle level or higher without touching the other leg or using any assistance and then stood on that leg for as long as possible barefoot and with eyes open. The observer measured the length of time for which participants maintained balance; that is, until they were no longer able to keep the leg raised at or above the ankle level or when both legs touched the ground. The observer stopped counting at 45 seconds, recording this as the time for any participant who maintained balance for a longer time. Each participant performed the test three times for both right and left legs, with the best result for each leg recorded.
Time Frame
5 minutes/session; measured at weeks 0, 6, and 12 of the experiment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
40-80 years of age
medical diagnoses of diabetes under regular medication control and diabetic peripheral neuropathy confirmed using an electrodiagnostic test
independent community ambulatory individuals
intact cognition (Mini-Mental State Examination score of >24).
Exclusion Criteria:
other neurological diseases such as dementia, Parkinson's disease, spinal cord injury, or stroke;
severe visual impairment, musculoskeletal disorders, unhealed plantar ulceration, lower limb amputation, poor cardiopulmonary function, or other diseases affecting walking ability or any other disease due to which individuals were unable to walk without assistance
any other condition associated with a high risk of falling.
Inability to follow simple instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Video Game Balance Training for Patients With Diabetic Neuropathy
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