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Effects of Virtual Reality-based Balance Training on Balance of Diabetic Peripheral Neuropathy Patients

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Virtual Reality
Conventional Physical Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring Virtual Reality, Balance Training, Balance, Diabetic Peripheral Neuropathy, Randomized Control Trial

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults age (45-65 years)
  • Male and female (both gender)
  • Medical diagnoses of type-II diabetes
  • DPN confirmed by physician
  • Stages ( Ia - sign but no symptoms of neuropathy, Ib - symptomatic mild diabetic poly neuropathy, sensory, motor or autonomic symptoms; patient able to heel walk)
  • Patients independent in transfer.
  • Unimpaired cognition/intelligence (Mini Mental State Examination Score of >24)

Exclusion Criteria:

  • Any neurological diseases e.g. Dementia, Parkinson, Stroke
  • Severe visual impairment and Cardiopulmonary disease
  • Musculoskeletal disorder, any disease due to individual were unable to walk and lower limb amputation
  • Disease which has chances of falling

Sites / Locations

  • Ripah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Virtual Reality

Conventional Physical Therapy

Arm Description

Virtual reality workout session will be for about 50 minutes in which warm-up exercise will be for 5 minutes including relaxed breathing, selected exercises for dynamic balance and static balance will take 40 minutes of the session in which games; tilt city, soccer heading, table tilt game, and penguin tilt will be used for dynamic balance training. For static balance training games will be torso leg curl and single leg extension. After that 5 minutes will be given for cools down.

Conventional physical therapy will be provided to this group for 50 minutes, with one minute of rest for every five minutes of exercise. Warm-up for 5 minutes, balancing-drills for 40 minutes, and cools down for five minutes. The session will include; slow and deep breathing exercise for about 3 minutes, patient will be asked to move both ankle joint to its complete range of movement for about five minutes, posture training for balance includes standing from sitting for five times, shifting the weight of the body while standing at one place for five times, move the body to the side and forward to aim the objective set by the therapist for five times, lift or raise the heels for five times of both foot for 20 seconds for each rise, to stand on one foot for 15 seconds, five times, to stand on one foot and bend the knee for about 15 seconds, five times. Wobble board preparation gait training and spot marching will be performed for about 5 to 6 minutes each.

Outcomes

Primary Outcome Measures

Berg balance scale
The Berg Balance Scale is used to objectively determine a patient's ability or inability to safely balance during a series of predetermined tasks. Berg Balance Scale (BBS) is a 14-item objective measure that assesses static balance and fall risk in adults. Berg balance scale scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. In general, Berg balance scale scores are interpreted as such: 0 to 20: A person with a score in this range will likely need the assistance of a wheelchair to move around safely.
Single leg standing test
Single leg standing test used to assess static postural and balance control. ... Client must stand unassisted on one leg, timed from the time the other foot leaves the ground till when the foot touches the ground again or the arms leave the hips. Participants unable to perform the one-leg stand for at least 5 seconds are at increased risk for injurious fall.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
June 27, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05258240
Brief Title
Effects of Virtual Reality-based Balance Training on Balance of Diabetic Peripheral Neuropathy Patients
Official Title
A Randomized Controlled Trial On The Effects Of Virtual Reality-Based Balance Training On Balance In Patients With Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
The study aimed to clarify the effect of virtual reality-based balance training on balance in patients with diabetic peripheral neuropathy compared to conventional physical therapy.
Detailed Description
A randomized control trial will be conducted at the study setting Safi Hospital Faisalabad after the approval of the synopsis. The study will be a single-blinded randomized control study. A convenient sampling technique will be used for the enrollment of the patient. Patient selection will be done based on defined insertion and omission criteria. Two groups would be made, the intervention group would receive the virtual gaming exercise tutoring and the control group would receive the regular physiotherapy exercises. The evaluation of the patients will be done at the start of the study, after six weeks, and after twelve weeks. Follow-up will be in the 16th weeks after the cessation of therapy. The patient's outcome will be measured on Berg Balance Scale and the Single Leg Stance test and the patient's data will be recorded before and after treatment, comparisons between before the treatment and after the treatment data will be made after 12 weeks. Informed consent/approval would be taken from each patient. Analysis and entry of data will be done by Statistical Package of Social Sciences Version 22 Software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
Keywords
Virtual Reality, Balance Training, Balance, Diabetic Peripheral Neuropathy, Randomized Control Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The study would be single-blinded as assessor of the study would be kept blind of the treatment group to which the patient will be allocated.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Other
Arm Description
Virtual reality workout session will be for about 50 minutes in which warm-up exercise will be for 5 minutes including relaxed breathing, selected exercises for dynamic balance and static balance will take 40 minutes of the session in which games; tilt city, soccer heading, table tilt game, and penguin tilt will be used for dynamic balance training. For static balance training games will be torso leg curl and single leg extension. After that 5 minutes will be given for cools down.
Arm Title
Conventional Physical Therapy
Arm Type
Other
Arm Description
Conventional physical therapy will be provided to this group for 50 minutes, with one minute of rest for every five minutes of exercise. Warm-up for 5 minutes, balancing-drills for 40 minutes, and cools down for five minutes. The session will include; slow and deep breathing exercise for about 3 minutes, patient will be asked to move both ankle joint to its complete range of movement for about five minutes, posture training for balance includes standing from sitting for five times, shifting the weight of the body while standing at one place for five times, move the body to the side and forward to aim the objective set by the therapist for five times, lift or raise the heels for five times of both foot for 20 seconds for each rise, to stand on one foot for 15 seconds, five times, to stand on one foot and bend the knee for about 15 seconds, five times. Wobble board preparation gait training and spot marching will be performed for about 5 to 6 minutes each.
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Intervention Description
Virtual reality workout enhances balance control, self-reported balance and mental stability in healthy and stable adults. Sensory-based exercise and the response to visual acuity can increase the patient's ability to maintain their body in a stable position.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
Postural training, standing, walking, and walking activities are included in the conventional physical therapy in domain of balance exercise training programs. These activities are usually boring and tedious because these exercises are repeated many times.
Primary Outcome Measure Information:
Title
Berg balance scale
Description
The Berg Balance Scale is used to objectively determine a patient's ability or inability to safely balance during a series of predetermined tasks. Berg Balance Scale (BBS) is a 14-item objective measure that assesses static balance and fall risk in adults. Berg balance scale scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. In general, Berg balance scale scores are interpreted as such: 0 to 20: A person with a score in this range will likely need the assistance of a wheelchair to move around safely.
Time Frame
12th Week
Title
Single leg standing test
Description
Single leg standing test used to assess static postural and balance control. ... Client must stand unassisted on one leg, timed from the time the other foot leaves the ground till when the foot touches the ground again or the arms leave the hips. Participants unable to perform the one-leg stand for at least 5 seconds are at increased risk for injurious fall.
Time Frame
12th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults age (45-65 years) Male and female (both gender) Medical diagnoses of type-II diabetes DPN confirmed by physician Stages ( Ia - sign but no symptoms of neuropathy, Ib - symptomatic mild diabetic poly neuropathy, sensory, motor or autonomic symptoms; patient able to heel walk) Patients independent in transfer. Unimpaired cognition/intelligence (Mini Mental State Examination Score of >24) Exclusion Criteria: Any neurological diseases e.g. Dementia, Parkinson, Stroke Severe visual impairment and Cardiopulmonary disease Musculoskeletal disorder, any disease due to individual were unable to walk and lower limb amputation Disease which has chances of falling
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Kashif
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Ripah International University
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Virtual Reality-based Balance Training on Balance of Diabetic Peripheral Neuropathy Patients

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