Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Foot Exercise People With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064996
Recruitment Status : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Evrim KOÇARSLAN, Istanbul University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Peripheral Neuropathy Other: Routine rehabilitation program patient education Other: Routine rehabilitation program + foot exercise training Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Foot Exercise Training on Patients With Type 2 Diabetes and Peripheral Neuropathy
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
Routine rehabilitation program patient education
Other: Routine rehabilitation program patient education

Patient education

All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS), hand-held dynamometer, range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test, circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment.


Experimental: Group B
Routine rehabilitation program + foot exercise training
Other: Routine rehabilitation program + foot exercise training

In addition to the patient education , foot exercise training will be performed. Patients will be applied exercise training consisted of aerobic, strengthening, sensory training and stretching exercises for 3 days/week, 8 weeks.

All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) ,hand-held dynamometer,range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test,circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment.





Primary Outcome Measures :
  1. Pain assessment with Algometry [ Time Frame: Change from Baseline Pain at 8 weeks ]
    An instrument for determining sensitivity to pain produced by pressure.

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. Muscle Strength with Hand held dynamometer [ Time Frame: 1th day, 4th week, 8th week ]
    The Hand-Held Dynamometer (formerly known as the Manual Muscle Tester) is an ergonomic hand-held device for objectively quantifying muscle strength.

  2. Range Of Motion with goniometer [ Time Frame: 1th day, 4th week, 8th week ]
    A goniometer is a device used in physical therapy to measure the range of motion around a joint in the body.

  3. Baseline Tactile Semmes-Weinstein Monofilament [ Time Frame: 1th day, 4th week, 8th week ]
    Baseline Tactile Semmes-Weinstein Monofilaments are designed to measure cutaneous sensory perception threshold of a patient.

  4. Edema measurement of tape [ Time Frame: 1th day, 4th week, 8th week ]
    Use a measuring tape to measure the circumference of your leg. Write down its circumference and repeat daily for a few days, using the same area on your the leg.

  5. Evaluation of functional capacity with 6 minutes walking test [ Time Frame: 1th day, 4th week, 8th week ]
    The 6-minute walk test is one of the functional exercise capacity assessment tests. In this test, participants are asked to walk as long as possible within 6 minutes in a 30 meter (m) corridor. When they feel fatigue or pain, they are advised to stop and rest when they feel ready to walk. At the end of 6 minutes, the total distance of the patients walking is recorded. Heart rates, systolic and diastolic blood pressures, O2 saturation, perceived fatigue and dyspnea levels are recorded before and after the test.

  6. Two Point Discrimation Test [ Time Frame: 1th day, 4th week, 8th week ]
    The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064996


Locations
Layout table for location information
Turkey
Istanbul University
Istanbul, Turkey
Sponsors and Collaborators
Istanbul University
Investigators
Layout table for investigator information
Principal Investigator: Evrim Koçarslan researcher

Publications:
Layout table for additonal information
Responsible Party: Evrim KOÇARSLAN, physiotherapist, Istanbul University
ClinicalTrials.gov Identifier: NCT04064996     History of Changes
Other Study ID Numbers: 199292
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evrim KOÇARSLAN, Istanbul University:
foot exercise
pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Nervous System Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases