The Effect of the Physiotherapy Program for Diabetic Individuals on Dexterity, Proprioception, and Functionality

NCT05974878 | Completed DMC

• 1 other identifier: 2023/45
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of our research titled "The effect of the exercise program developed for the upper extremity in diabetic individuals on dexterity, grip strength and proprioception" is to examine the effect of the exercise program created for upper extremity problems in diabetic individuals on dexterity, wrist proprioception and upper extremity functionality. Secondary aims of our study; the exercise program created for upper extremity problems; to investigate the effects of grip strength, neuropathic pain, light touch, proprioception, muscle viscoelastic properties, anxiety and depression levels and quality of life of individuals. The strength of different grip types will be measured, and an evaluation will be made in a short time from the muscle surface with a device called MyotonPro to determine the characteristics of the muscles in hands and arms. In addition to these, 6 separate questionnaires will evaluate the functionality of hands, wrists and upper extremities, pain level, satisfaction level, difficulty level in daily living activities, neuropathic pain problems, depression and anxiety levels and quality of life. In addition, different senses in the upper extremity and hand-wrist will be tested. These measurements will take 1 hour in total and will be repeated 3 times at 6-week intervals. Participant will divide on 2 groups and treatment group will perform exercises with physiotherapist and control group will take conventional physiotherapy program for diabetes. Comparison will be between groups.

Conditions

Diabetes Mellitus Type 2

Keywords

diabetes; upper extremity; hand; exercise; proprioception; dexterity; functionality

Outcome Measures

Primary Outcomes (3)

• Proprioception

  35 degrees wrist flexion and 45 degrees wrist extension will be taught to the patient, and the patient will be asked to bring the wrist to the same position with eyes closed, and the angle of deviation will be measured with a goniometer and recorded.

  From enrollment to the end of treatment at 12 weeks, and at 6th week

• Dexterity

  The 9-Hole Peg Test, which is a valid and reliable assessment method, will be used to evaluate the hand and finger dexterity of the patients. Randomly placing 9 wooden pins on the 9-hole wooden block as quickly as possible and then removing the pins one by one from the wooden block and placing them in the storage section will be recorded by measuring with a stopwatch. By calculating the total time, 20 seconds or more will be considered as a loss of skill.

  From enrollment to the end of treatment at 12 weeks, and at 6th week

• Functionality

  The Quick Diasbilities of Arm, Shoulder and Hand (DASH) questionnaire will be used to determine the level and symptoms of physical disability in the upper extremity. Higher scores indicate higher disability in the upper extremity. The Michigan Hand Outcome Questionnaire is used to evaluate complaints in the hands of patients. It can evaluate each hand separately and was developed to evaluate the symptoms of all hand disorders. The parameters it evaluates respectively; function, daily activities, work performance, pain, aesthetics, satisfaction. A high score in the pain domain indicates worsening, and a high score in all other domains indicates a better condition. The total score is obtained by summing the results of the affected extremity or, if bilateral extremities are affected, by adding the mean scores of the areas and dividing by six. This questionnaire is valid and reliable for Turkish society.

  From enrollment to the end of treatment at 12 weeks, and at 6th week

Secondary Outcomes (7)

• Grip strength

  From enrollment to at the end of treatment at 12 weeks, and at the 6th week

• Pinch strength

  From enrollment to at the end of treatment at 12 weeks, and at the 6th week

• Neuropathic pain

  From enrollment to at the end of treatment at 12 weeks, and at the 6th week

• Sensations

  From enrollment to at the end of treatment at 12 weeks, and at the 6th week

• Hand muscles viscoelastic properties

  From enrollment to at the end of treatment at 12 weeks, and at the 6th week

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants in this group are going to be in physiotherapy program, which is created specific to diabetic patients, contains; * Exercises for stability, flexibility and strength, * Exercises which improves wrist proprioception, * Exercises for sensation recovery, * Mirror therapy and motor imagination * Physiotherapy program will be changed in every 3 weeks. Participant will be informed about their disease, about process of healing and will check by phone calls 2 times a week. They will be given recommendations about disease management. Home exercises will be given to this group and will be added new exercises every 3 weeks while physiotherapy program continues.

Other: Exercise

Control Group

EXPERIMENTAL

Control group will take conventional physiotherapy as in the literature. Diabetic individuals in routine takes aerobic exercise recommendation and resistive exercises. In our study control group will continue 12 sessions of resistive exercise program focused on upper extremity, also aerobic exercise recommendation.

Other: Conventional Physiotherapy

Interventions

Exercise OTHER

* Joints targeted by exercise; bilateral wrist, metacarpophalangeal, proximal and distal interphalangeal joints, elbow and shoulder joints. * The muscles targeted by the exercises; lumbricals, iinterosseals, thenar and hypothenar muscles, forearm flexors, forearm extensors, forearm supinators and pronators, elbow flexors and extensors, and shoulder girdle muscles. * Content of the exercises; There will be warm-up exercises, pinch grip, full grip, nerve and tendon gliding exercises, exercises that improve proprioception, functional exercises, strengthening exercises and stretching exercises.

Treatment Group

Conventional Physiotherapy OTHER

For control group there will be aerobic exercise recommendation and resistive exercises focused on upper extremity.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the research
• Being diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA)

You may not qualify if:

• Insufficient cognitive level
• Traumatic nerve injury
• Presence of congenital anomaly in the upper extremity
• Presence of systematic disease (eg rheumatologic)
• Having a problem involving the neurological system
• Having undergone surgery involving the upper extremity in the last 6 months

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Sahinbey, 27100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zeynep I BULUT, Mac

  Hasan Kalyoncu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: August 3, 2023
• Study Start: May 18, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 19, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

TU (1)