Diabetic Neuropathy With Neurologic ComplicationNCT04232995
Balance Training in Diabetic Neuropathy
A study testing Balance Training and General Exercises in people with Diabetic Neuropathy With Neurologic Complication, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This study evaluates the efficacy of balance training in Diabetic Neuropathy. Control group will receive general exercises while Eperimental/ Interventional group will receive Balance exercises along with general exercises. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetic Neuropathy With Neurologic Complication
- What is being tested?
- Balance Training and General Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Mar 2019to 1 Nov 2020
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group: 30-60 years
- Diabetes type II patients diagnosed with peripheral neuropathy by medical doctor for at least 5 years
- Neuropathy present (on the basis of Michigan Neuropathy Screening Instrument
- Have balance impairment ( evaluation on Berg Balance Scale)
Who cannot join
- Neuropathy due to other medical conditions like Vitamin deficiency, Hypothyroidism, Auto-immune/ demyelinating diseases
- Foot ulcers
- Lower limb amputee
- Vestibular diseases
- Retinopathy
- Cardiac problems
- Hemiplegia/ Stroke
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences
Karachi, Sindh, 74200
About this study
Official title: Efficacy of Balance Training in Comparison to General Exercises Alone in Diabetic Neuropathy
This study evaluates the efficacy of balance training in Diabetic Neuropathy. Control group will receive general exercises while Eperimental/ Interventional group will receive Balance exercises along with general exercises.
- Being tested
- Balance Training, General Exercises
- Keywords
- Diabetes Mellitus type 2, Diabetic neuropathy, Rehabilitation, Balance exercises, Berg Balance Scale
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance TrainingOther
Balance enhancing exercises
General ExercisesOther
General Exercises
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Balance training by 9 positions with 1 min hold, repeated twice
1. Stand with feet together, eyes remain open
2. Stand with together, eyes closed
3. \& 4) Tandem Standing with Right and Left in front alternately
5) Forward Reaching 6) \& 7) Single Leg Standing, with Right and Left foot alternately 8) \& 9) Step up, with Right and Left foot alternately
General Exercises for 25 min
* Active Range of Motion Exercises and Foot Care Education-5 min
* Treadmill- 15 min
* Cycling -5 min
No. Of Sessions 24, thrice a week for 8 weeks Receives: Other: Balance Training; Other: General Exercises |
| Control Group | Active comparator | General Exercises for 25 min
* Active Range of Motion Exercises and Foot Care Education-5 min
* Treadmill- 15 min
* Cycling -5 min
No. Of Sessions 24, thrice a week for 8 weeks Receives: Other: General Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)
Measured: Baseline (Pre treatment)
Berg Balance Scale
The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)
Measured: At 4th week of treatment
Berg Balance Scale
The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)
Measured: At 8th week of treatment (Post treatment )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start12 Mar 2019
- Primary completion1 Sep 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy With Neurologic ComplicationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabeiya Tazeem, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232995
- Sponsor's protocol ID
- RTazeem
- Status last verified
- Aug 2021
- First submitted
- 11 Jan 2020
- Last updated
- 19 Aug 2021
- 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 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Balance Training in Comparison to General Exercises Alone in Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT04232995
- Acronym / sponsor ID
- RTazeem
- Keywords
- Diabetes Mellitus type 2, Diabetic neuropathy, Rehabilitation, Balance exercises, Berg Balance Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 18 Jan 2020 (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.
This study evaluates the efficacy of balance training in Diabetic Neuropathy. Control group will receive general exercises while Eperimental/ Interventional group will receive Balance exercises along with general exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Balance Training, Other: General ExercisesBalance training by 9 positions with 1 min hold, repeated twice 1. Stand with feet together, eyes remain open 2. Stand with together, eyes closed 3. \& 4) Tandem Standing with Right and Left in front alternately 5) Forward Reaching 6) \& 7) Single Leg Standing, with Right and Left foot alternately 8) \& 9) Step up, with Right and Left foot alternately General Exercises for 25 min * Active Range of Motion Exercises and Foot Care Education-5 min * Treadmill- 15 min * Cycling -5 min No. Of Sessions 24, thrice a week for 8 weeks |
| Control Group | Active comparator | Other: General ExercisesGeneral Exercises for 25 min * Active Range of Motion Exercises and Foot Care Education-5 min * Treadmill- 15 min * Cycling -5 min No. Of Sessions 24, thrice a week for 8 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age group: 30-60 years
- Diabetes type II patients diagnosed with peripheral neuropathy by medical doctor for at least 5 years
- Neuropathy present (on the basis of Michigan Neuropathy Screening Instrument
- Have balance impairment ( evaluation on Berg Balance Scale)
Key exclusion criteria (7 listed)
- Neuropathy due to other medical conditions like Vitamin deficiency, Hypothyroidism, Auto-immune/ demyelinating diseases
- Foot ulcers
- Lower limb amputee
- Vestibular diseases
- Retinopathy
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 |
|---|---|---|
| Balance TrainingBalance enhancing exercises | Other | Experimental Group |
| General ExercisesGeneral Exercises | Other | Control Group, Experimental Group |
Primary outcome
Berg Balance Scale
Time frame: Baseline (Pre treatment)
The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)
Berg Balance Scale
Time frame: At 4th week of treatment
The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)
Berg Balance Scale
Time frame: At 8th week of treatment (Post treatment )
The Berg Balance Scale (BBS) is a 56-point scale that evaluates 14 tasks. Katherine Berg developed this test to assess the level of function and balance in various patient populations. Minimum score is 0 (means severe balance deficit) and Maximum score is 56 (means No balance deficit)
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 19 Aug 2021.
- Individual participant dataSharing planned: No
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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 Balance Training and General Exercises in people with Diabetic Neuropathy With Neurologic Complication, run by Dow University of Health Sciences 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 7 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 19 Aug 2021. 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: Baseline (Pre treatment)). The study lists 3 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 19 Aug 2021.