Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 440 for:    Taipei Medical University Hospital

Video Game Balance Training for Patients With Diabetic Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03676595
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Lai chien hung, Taipei Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Peripheral Other: interactive video game-based exercise Other: no exercise Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Interactive Video Game-Based Exercise on Balance in Diabetic Patients With Peripheral Neuropathy
Actual Study Start Date : November 20, 2013
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.

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.

Experimental: 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.
Other: 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.

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.




Primary Outcome Measures :
  1. Change of Berg Balance Scale (BBS) score [ Time Frame: 15 minutes/session; measured at weeks 0, 6, and 12 of the experiment ]
    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 :
  1. Change of Time Up and Go (TUG) test time [ Time Frame: 5 minutes/session; measured at weeks 0, 6, and 12 of the experiment ]
    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.

  2. Change of Modified Falls Efficacy Scale (MFES) scores [ Time Frame: 10 minutes/session; measured at weeks 0, 6, and 12 of the experiment ]
    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.

  3. Change of Unipedal Stance Test (UST) time [ Time Frame: 5 minutes/session; measured at weeks 0, 6, and 12 of the experiment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676595


Sponsors and Collaborators
Taipei Medical University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chien-Hung Lai Taipei Medical University Hospital

Layout table for additonal information
Responsible Party: Lai chien hung, Professor, Taipei Medical University Hospital
ClinicalTrials.gov Identifier: NCT03676595     History of Changes
Other Study ID Numbers: 201308020
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases