Diabetic Peripheral NeuropathyNCT06740227
Effects of Virtual Reality-Based Balance Training Compared to Conventional Balance Training to Reduce Risk of Fall in Patients With Diabetic Peripheral Neuropathy: A Randomized Control Trial
A study testing Virtual Reality-Based Balance Training and Conventional Balance Training in people with Diabetic Peripheral Neuropathy and Balance, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The objective of this study is to determine the effects of virtual reality based balance training compared to conventional balance training to reduce risk of fall in patients with diabetic peripheral neuropathy in terms of fall and gait parameters. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Balance, Fall Risk
- What is being tested?
- Virtual Reality-Based Balance Training and Conventional Balance Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jul 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40 years and above
- Medical Diagnosis of diabetes under regular medication control and Diabetic Peripheral Neuropathy (DPN) confirmed
- Independent community ambulatory individuals
- Intact cognition (MMSE > 24)
Who cannot join
- Other neurological conditions I.e. Dementia, Parkinson Disease, Spinal Cord Injury or Stroke.
- Severe visual impairment, Musculoskeletal disorders, Unhealed plantar ulceration, Lower limb amputation, poor cardiopulmonary function or other disease that affects walking ability or any other disease due to which individuals are unable to walk without assistance.
- Any other condition associated with high risk of fall.
- Inability to follow simple instructions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Islamabad, Punjab Province, 44000
About this study
The objective of this study is to determine the effects of virtual reality based balance training compared to conventional balance training to reduce risk of fall in patients with diabetic peripheral neuropathy in terms of fall and gait parameters.
The study is a non-blinded randomized control trial, consisting of 2 groups. The Study will be conducted at Fauji Foundation Hospital and Foundation University Islamabad. A calculated sample of 30 subjects will be selected via non-probability convenience sampling technique followed by randomization into two groups using envelope method.
Read more
After CBRC registration, ethical approval is obtained from ERC FUMC. Individuals fulfilling the inclusion criteria is selected, followed by written informed consent after explaining the study purpose.
Participants is then be randomly allocated to one of the 2 groups. At the baseline, Fall Efficacy Scale (FES), Activity-specific Balance Confidence (ABC), Time Up and Go Test and Dynamic Gait Index (DGI) are assessed.
Control group is provided with conventional balance training. Treatment group is provided with the Virtual Reality (Wii Fit) Based Balance Training.
Exercise training is performed thrice a week on alternate days for a total duration of 18 sessions over 06 week.
All outcome measurements would be performed before and then after the 6-weeks intervention period.
Data will be entered and analyzed on SPSS v. 22.
- Conditions
- Diabetic Peripheral Neuropathy, Balance, Fall Risk
- Being tested
- Virtual Reality-Based Balance Training, Conventional Balance Training
- Keywords
- Diabetic Peripheral Neuropathy (DPN), Peripheral Nervous System Disease, Hyperglycemia-Induced Neuropathy, Neuropathic Pain, Sensory Disorder, Motor Neuron Disease, Metabolic Disease, Blood Glucose Regulation Disorders, Hyperglycemia, Small Fiber Neuropathy,, Virtual Reality Based Balance Training, Conventional Balance Training, Balance Rehabilitation, Fall prevention Intervention
- Medical subject headings
- Peripheral Nervous System Diseases, Neuralgia, Sensation Disorders, Motor Neuron Disease, Metabolic Diseases, Hyperglycemia, Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Based Balance TrainingProcedure or surgery
Virtual reality workout session will be for about 30-40 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For Static Balance, Lotus Focus, Tree pose, Warrior Pose games will be used For Dynamic Balance, Soccer Heading, Ski Jump, Tight Rope Walk, Table Tilt, Ski Slalom games will be used 5 minutes will be given for cool down.
Conventional Balance TrainingProcedure or surgery
one minute of rest for every five minutes of exercise Conventional Balance workout session will be for about 30-40 minutes Warm-up for 5 minutes For Static Balance, Static Balance, Single Leg Standing, Stork Standing will be used For Dynamic Balance, Weight Shifts, Tandem Walk, Single Leg Balance with Arm Movements 5 minutes will be given for cool down
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Conventional Balance Training one minute of rest for every five minutes of exercise
Conventional Balance workout session will be for about 30-40 minutes Warm-up for 5 minutes For Static Balance, Static Balance, Single Leg Standing, Stork Standing will be used For Dynamic Balance, Weight Shifts, Tandem Walk, Single Leg Balance with Arm Movements 5 minutes will be given for cool down Receives: Procedure: Conventional Balance Training |
| Experimental group | Experimental | Virtual Reality based balance training
Virtual reality workout session will be for about 30-40 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For Static Balance, Lotus Focus, Tree pose, Warrior Pose games will be used For Dynamic Balance, Soccer Heading, Ski Jump, Tight Rope Walk, Table Tilt, Ski Slalom games will be used 5 minutes will be given for cool down. Receives: Procedure: Virtual Reality-Based Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Fall
It is a Fall Efficacy Scale (FES) is a self-revealed measure fear of fall. The FES comprises of 10 things, each addressing a typical action of day to day living, like cleaning, dressing, or walking. Respondents rate their certainty for every movement on a 10-point Likert scale, where 1 specifies "not confident at all" and 10 implies "completely confident." The all out score, got by adding the appraisals across all things, goes from 10 (least certainty) to 100 (most noteworthy certainty).
Measured: 6 weeks
Balance
Activity Specific Balance Confidence (ABC) Scale is used particularly in assessing balance confidence among individuals, especially older adults, who may have concerns about falling during daily activities.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Jul 2024
- Primary completion15 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740227
- Sponsor's protocol ID
- FUI/CTR/2024/59
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality-Based Balance Training Compared to Conventional Balance Training to Reduce Risk of Fall in Patients With Diabetic Peripheral Neuropathy: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06740227
- Acronym / sponsor ID
- FUI/CTR/2024/59
- Conditions
- Diabetic Peripheral Neuropathy, Balance, Fall Risk
- Keywords
- Diabetic Peripheral Neuropathy (DPN), Peripheral Nervous System Disease, Hyperglycemia-Induced Neuropathy, Neuropathic Pain, Sensory Disorder, Motor Neuron Disease, Metabolic Disease, Blood Glucose Regulation Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the effects of virtual reality based balance training compared to conventional balance training to reduce risk of fall in patients with diabetic peripheral neuropathy in terms of fall and gait parameters.
The study is a non-blinded randomized control trial, consisting of 2 groups. The Study will be conducted at Fauji Foundation Hospital and Foundation University Islamabad. A calculated sample of 30 subjects will be selected via non-probability convenience sampling technique followed by randomization into two groups using envelope method.
After CBRC registration, ethical approval is obtained from ERC FUMC. Individuals fulfilling the inclusion criteria is selected, followed by written informed consent after explaining the study purpose.
Participants is then be randomly allocated to one of the 2 groups. At the baseline, Fall Efficacy Scale (FES), Activity-specific Balance Confidence (ABC), Time Up and Go Test and Dynamic Gait Index (DGI) are assessed.
Control group is provided with conventional balance training. Treatment group is provided with the Virtual Reality (Wii Fit) Based Balance Training.
Exercise training is performed thrice a week on alternate days for a total duration of 18 sessions over 06 week.
All outcome measurements would be performed before and then after the 6-weeks intervention period.
Data will be entered and analyzed on SPSS v. 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Conventional Balance TrainingConventional Balance Training one minute of rest for every five minutes of exercise Conventional Balance workout session will be for about 30-40 minutes Warm-up for 5 minutes For Static Balance, Static Balance, Single Leg Standing, Stork Standing will be used For Dynamic Balance, Weight Shifts, Tandem Walk, Single Leg Balance with Arm Movements 5 minutes will be given for cool down |
| Experimental group | Experimental | Procedure: Virtual Reality-Based Balance TrainingVirtual Reality based balance training Virtual reality workout session will be for about 30-40 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For Static Balance, Lotus Focus, Tree pose, Warrior Pose games will be used For Dynamic Balance, Soccer Heading, Ski Jump, Tight Rope Walk, Table Tilt, Ski Slalom games will be used 5 minutes will be given for cool down. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 40 years and above
- Medical Diagnosis of diabetes under regular medication control and Diabetic Peripheral Neuropathy (DPN) confirmed
- Independent community ambulatory individuals
- Intact cognition (MMSE > 24)
Key exclusion criteria (4 listed)
- Other neurological conditions I.e. Dementia, Parkinson Disease, Spinal Cord Injury or Stroke.
- Severe visual impairment, Musculoskeletal disorders, Unhealed plantar ulceration, Lower limb amputation, poor cardiopulmonary function or other disease that affects walking ability or any other disease due to which individuals are unable to walk without assistance.
- Any other condition associated with high risk of fall.
- Inability to follow simple instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Based Balance TrainingVirtual reality workout session will be for about 30-40 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For Static Balance, Lotus Focus, Tree pose, Warrior Pose games will be used For Dynamic Balance, Soccer Heading, Ski Jump, Tight Rope Walk, Table Tilt, Ski Slalom games will be used 5 minutes will be given for cool down. | Procedure or surgery | Experimental group |
| Conventional Balance Trainingone minute of rest for every five minutes of exercise Conventional Balance workout session will be for about 30-40 minutes Warm-up for 5 minutes For Static Balance, Static Balance, Single Leg Standing, Stork Standing will be used For Dynamic Balance, Weight Shifts, Tandem Walk, Single Leg Balance with Arm Movements 5 minutes will be given for cool down | Procedure or surgery | Control Group |
Primary outcome
Fear of Fall
Time frame: 6 weeks
It is a Fall Efficacy Scale (FES) is a self-revealed measure fear of fall. The FES comprises of 10 things, each addressing a typical action of day to day living, like cleaning, dressing, or walking. Respondents rate their certainty for every movement on a 10-point Likert scale, where 1 specifies "not confident at all" and 10 implies "completely confident." The all out score, got by adding the appraisals across all things, goes from 10 (least certainty) to 100 (most noteworthy certainty).
Balance
Time frame: 6 weeks
Activity Specific Balance Confidence (ABC) Scale is used particularly in assessing balance confidence among individuals, especially older adults, who may have concerns about falling during daily activities.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Based Balance Training and Conventional Balance Training in people with Diabetic Peripheral Neuropathy and Balance, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Fall (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.