Diabetic Neuropathy With Neurologic Complication Clinical Trial
Official title:
Efficacy of Balance Training in Comparison to General Exercises Alone in Diabetic Neuropathy
| NCT number | NCT04232995 |
| Other study ID # | RTazeem |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 12, 2019 |
| Est. completion date | November 1, 2020 |
| Verified date | August 2021 |
| Source | Dow University of Health Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | November 1, 2020 |
| Est. primary completion date | September 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 60 Years |
| Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Pakistan | Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences | Karachi | Sindh |
| Lead Sponsor | Collaborator |
|---|---|
| Dow University of Health Sciences |
Pakistan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | Baseline (Pre treatment) | |
| Primary | 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) | At 4th week of treatment | |
| Primary | 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) | At 8th week of treatment (Post treatment ) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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