Diabetic Peripheral NeuropathyNCT05258240
Effects of Virtual Reality-based Balance Training on Balance of Diabetic Peripheral Neuropathy Patients
A study testing Virtual Reality and Conventional Physical Therapy in people with Diabetic Peripheral Neuropathy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Virtual Reality and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 25 Mar 2022
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: A Randomized Controlled Trial On The Effects Of Virtual Reality-Based Balance Training On Balance In Patients With Diabetic Peripheral Neuropathy
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Virtual Reality, Conventional Physical Therapy
- Keywords
- Virtual Reality, Balance Training, Balance, Diabetic Peripheral Neuropathy, Randomized Control Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
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.
Conventional Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Other | 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. Receives: Other: Virtual Reality |
| Conventional Physical Therapy | Other | 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. Receives: Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12th Week
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.
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Mar 2021
- Primary completion17 Mar 2022
- Study completion25 Mar 2022
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.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258240
- Sponsor's protocol ID
- REC-FSD-00296
- Status last verified
- Jun 2022
- First submitted
- 20 Feb 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial On The Effects Of Virtual Reality-Based Balance Training On Balance In Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05258240
- Acronym / sponsor ID
- REC-FSD-00296
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Virtual Reality, Balance Training, Balance, Diabetic Peripheral Neuropathy, Randomized Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 28 Feb 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Other | Other: Virtual RealityVirtual 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 | Other | Other: Conventional Physical TherapyConventional 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 RealityVirtual 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. | Other | Virtual Reality |
| Conventional Physical TherapyPostural 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. | Other | Conventional Physical Therapy |
Primary outcome
Berg balance scale
Time frame: 12th Week
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
Time frame: 12th Week
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.
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 1 Jul 2022.
- Individual participant dataSharing planned: No
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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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.
Muhammad Kashif study chair
Riphah International University
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 and Conventional Physical Therapy in people with Diabetic Peripheral Neuropathy, run by Riphah International University 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 7 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 1 Jul 2022. 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?
Berg balance scale (time frame: 12th Week). 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 1 Jul 2022.