Clinical trial NCT03676595: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy Peripheral
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Berg Balance Scale (BBS) score
timeFrame: 15 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Secondary outcomes:
measure: Change of Time Up and Go (TUG) test time
timeFrame: 5 minutes/session; measured at weeks 0, 6, and 12 of the experiment
measure: Change of Modified Falls Efficacy Scale (MFES) scores
timeFrame: 10 minutes/session; measured at weeks 0, 6, and 12 of the experiment
measure: Change of Unipedal Stance Test (UST) time
timeFrame: 5 minutes/session; measured at weeks 0, 6, and 12 of the experiment
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University Hospital
name: Chien-Hung Lai
role: PRINCIPAL_INVESTIGATOR
References: