Effectiveness of Foot Exercise Training on Patients With Type 2 Diabetes and Peripheral Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Pain assessment with Algometry
Study Overview
Brief Summary
The aim of this study will to investigate the effect of foot exercises in patients with type 2 diabetic and peripheral neuropathy. Subjects will be randomly allocated to either the control or intervention group. Data will be collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks; the control group will be received standard treatment but no exercises. The intervention and control groups will be examined and measured at the 4th and 8th weeks.
Detailed Description
Purpose of our study investigation of the effects foot exercises in patients with type 2 diabetic and peripheral neuropathy.
Excepted results: Routine treatment + foot exercises pain, flexibility, edema, muscle strength, sensation, quality of life we believe that there will be good progress in peripheral neuropathy effects, Leeds assessment of neuropathic symptoms and signs(LANSS) results.
In this context, it is planned that patients randomly divided into 2 groups. Group 1 control group. Group 2 intervention group. Patients in the intervention group will be received standard treatment and performed foot exercises for three times a week 8 weeks. The patients will be evaluated by clinical measurements and scales based on patient notification at the 4th and 8th weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Having type 2 diabetes mellitus for 5 years
- •HbA1c > among of between 6.5-10
- •Having grade 0 or 1 phase of Wagner classification
- •Diabetic neuropathy score ≥ 3
Exclusion Criteria
- •Not to know turkish
- •Having hearing, visual and speaking problems
- •Having (except diabetic neuropathy) other neurologic problems
- •Having psychiatric and cognitive problems
- •Having orthopedic, rheumatologic, cardiac, and pulmonary problems which stopping exercise
Outcomes
Primary Outcomes
Pain assessment with Algometry
Time Frame: Change from Baseline Pain at 8 weeks
An instrument for determining sensitivity to pain produced by pressure.
Pain assessment With Visual Analog Scale
Time Frame: Change from Baseline Pain at 8 weeks
Participants are asked to mark the point where they feel their pain on a 10 centimeter (cm) horizontal line. 0-no pain, 10-unbearable pain. Night, activity and pain conditions are evaluated separately at rest.
Pain assessment with The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
Time Frame: Change from Baseline Pain at 8 weeks
The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale evaluates sensory dysfunction and whether the pain is caused by neuropathic mechanisms or not. The LANSS comprises a 5-item questionnaire regarding pain symptoms and two items for clinical signs involving self-administered sensory tests for the presence of allodynia and decreased sensation to pinprick. Responses to each item are binary (yes or no) and each item is weighted differently depending on the odds ratio of a positive response to each item to predict that the pain is primarily neuropathic. The possible scores range from 0 to 24, with a score of 12 or greater considered to be suggestive of neuropathic pain
Secondary Outcomes
- Muscle Strength with Hand held dynamometer(1th day, 8th week)
- Range Of Motion with goniometer(1th day, 8th week)
- Baseline Tactile Semmes-Weinstein Monofilament(1th day, 8th week)
- Edema measurement of tape(1th day, 8th week)
- Two Point Discrimation Test(1th day, 8th week)
- The Foot and Ankle Ability Measure(1th day, 8th week)
- HbA1c(1 th day, 8th week)
- Serum creatinine(1 th day, 8th week)
- Evaluation of functional capacity with 6 minutes walking test(1th day, 8th week)
- Albumin levels(1 th day, 8th week)
Investigators
Evrim KOÇARSLAN
physiotherapist
Istanbul University