Video Game Balance Training for Patients With Diabetic Neuropathy

NCT ID: NCT03676595

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-20
• Study Completion Date: 2018-01-31

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.

Conditions

Diabetic Neuropathy Peripheral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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 Type: EXPERIMENTAL

interactive video game-based exercise

Intervention Type: 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 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.

no exercise

Intervention Type: 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 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.

Group B

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.

Group Type: EXPERIMENTAL

interactive video game-based exercise

Intervention Type: 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 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.

no exercise

Intervention Type: 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 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.

Interventions

interactive video game-based exercise

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

no exercise

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lai chien hung

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chien-Hung Lai

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Other Identifiers

201308020

Identifier Type: -

Identifier Source: org_study_id