Video Game Balance Training for Patients With Diabetic Neuropathy

NCT03676595 | Completed DMC

• 1 other identifier: 201308020
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Neuropathy Peripheral

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Change of Time Up and Go (TUG) test time

  5 minutes/session; measured at weeks 0, 6, and 12 of the experiment

• Change of Modified Falls Efficacy Scale (MFES) scores

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

• Change of Unipedal Stance Test (UST) time

  5 minutes/session; measured at weeks 0, 6, and 12 of the experiment

Study Arms (2)

Group A

EXPERIMENTAL

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.

Other: interactive video game-based exercise; Other: no exercise

Group B

EXPERIMENTAL

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.

Other: interactive video game-based exercise; Other: no exercise

Interventions

interactive video game-based exercise 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 A; Group B

no exercise 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 A; Group B

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Officials

• Chien-Hung Lai

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 18, 2018
• Study Start: November 20, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09