Diabetes Mellitus Type 2NCT05974878
The Effect of the Physiotherapy Program for Diabetic Individuals on Dexterity, Proprioception, and Functionality
A study testing Exercise and Conventional Physiotherapy in people with Diabetes Mellitus Type 2, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Exercise and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2023to 19 Dec 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the research
- Being diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, Sahinbey, 27100
About this study
Official title: The Effect of the Physiotherapy Program Developed for the Upper Extremity in Diabetic Individuals on Dexterity, Proprioception, and Functionality
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.
Read the detailed description
- 12 weeks/ 3 days a week/ 40 minutes of physiotherapy program will be planned. Patients will complete the exercises with a physiotherapist once a week, and home programs given as homework according to weekly targets will be checked by phone calls twice a week. In the first session, information about diabetes will be given and training will be given.
- 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. Control group will be in conventional physiotherapy program once a week as treatment group. The program is going to include aerobic exercise recommendation and basic stretching and strengthening exercises focusing upper extremity muscles.
This research will shed light on the rehabilitation programs to be planned for problems involving the hand in individuals with diabetes.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Exercise, Conventional Physiotherapy
- Keywords
- diabetes, upper extremity, hand, exercise, proprioception, dexterity, functionality
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
- 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.
Conventional PhysiotherapyOther
For control group there will be aerobic exercise recommendation and resistive exercises focused on upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks, and at 6th week
Secondary outcomes (7)
Grip strength
Grip strength will be evaluated using the Jamar Dynamometer. The average of three attempts for each hand will be recorded in kilograms. This test is a reliable and valid test to evaluate manual grip strength.
Measured: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Pinch strength
Grip strength will be evaluated using the Jamar Pinchmeter. The average of three attempts for each hand will be recorded in kilograms. This test is a reliable and valid test to evaluate manual grip strength.
Measured: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Neuropathic pain
Mc Gill Pain Scale Short Form will be used in pain assessment. The scale consists of 3 sub-sections that evaluate the sensory and perceptual aspects of pain, the severity of pain, and whether there is currently pain. In the first part, there are 15 expressions describing pain and it is graded between 0 (absent) and 3 (severe). In the second part, the patient is expected to mark the severity of pain on a linear scale. In the third part, it evaluates whether the patient currently has pain, and if there is pain, its severity is evaluated with a visual comparison scale. The nature of neuropathic pain will be evaluated with the Neuropathic Pain Questionnaire Short Form (NPQ-SF). The NPQ-SF is a tool used to determine whether there is a complaint of neuropathic pain. It has 3 sub-parameters; tingling pain, increased pain and numbness from constant touch.
Measured: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Sensations
Two-point discrimination and light touch will be evaluated.
- Two-point separation; will be done using the discriminator. Two-point discrimination is made to determine the shortest distance that can be felt between two separate points on the skin. It is used to measure the fine work ability and sensitivity of the hand.
- Light touch; It will be evaluated with the Semmes-Weinstein Monofilament Test. The Semmes-Weinstein Monofilament kit consists of 20 nylon monofilament probes. It is a diagnostic test that objectively measures the touch threshold and is used to reveal the sensory level.
Measured: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Hand muscles viscoelastic properties
Myoton PRO device will be used to evaluate the viscoelastic properties of the muscle. Three measurements will be made by marking the muscles determined from the thenar (Abductor pollicis brevis) and hypothenar region (Abductor digiti minimi). Myoton PRO (Myoton AS, Tallinn, Estonia) is a handheld device that generates a mechanical impulse on the skin above the target structure. The measurement method implemented by Myoton PRO involves a mechanical pulse oscillating under a constant pressure. The oscillation of the tissue under the probe allows the viscoelastic properties of the tissue to be calculated.
Measured: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Depression level
Beck Depression Scale will be used to determine the level of depression. It was developed by Beck et al., and its validity and reliability study in our country was performed by Hisli. It contains a total of 21 self-evaluation sentences and is measured with a four-point Likert scale. Each item gets progressively increasing points between 0-3 and the total score varies between 0-63. The high total score indicates the high level of depression or its severity. In the Turkish validity and reliability study of the scale, the cut-off point was determined as 17. A study of the cut-off and psychometric properties of the Beck Depression Scale in the adult Turkish population Kapçı et al. made by. A total score of 0-10 = no depression, 11-17 = mild depression, 18-23 = moderate depression, 24 and above = severe depression.
Measured: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Anxiety level
Beck Anxiety Scale will be used to determine the level of anxiety. This scale is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3. The high total score indicates the high level of anxiety experienced by the person. It was developed by Beck et al., and its validity and reliability study in our country was performed by Ulusoy et al.
Measured: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start18 May 2023
- Primary completion1 Nov 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Irem BULUT, Hasan Kalyoncu University
- Investigators
- Zeynep I BULUT, Mac, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974878
- Sponsor's protocol ID
- 2023/45
- Status last verified
- Mar 2024
- First submitted
- 18 May 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Physiotherapy Program Developed for the Upper Extremity in Diabetic Individuals on Dexterity, Proprioception, and Functionality
- ClinicalTrials.gov ID
- NCT05974878
- Acronym / sponsor ID
- 2023/45
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- diabetes, upper extremity, hand, exercise, proprioception, dexterity, functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 3 Aug 2023 (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.
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.
Detailed description
- 12 weeks/ 3 days a week/ 40 minutes of physiotherapy program will be planned. Patients will complete the exercises with a physiotherapist once a week, and home programs given as homework according to weekly targets will be checked by phone calls twice a week. In the first session, information about diabetes will be given and training will be given.
- 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. Control group will be in conventional physiotherapy program once a week as treatment group. The program is going to include aerobic exercise recommendation and basic stretching and strengthening exercises focusing upper extremity muscles.
This research will shed light on the rehabilitation programs to be planned for problems involving the hand in individuals with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: ExerciseParticipants 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. |
| Control Group | Experimental | Other: Conventional PhysiotherapyControl 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteering to participate in the research
- Being diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Exercise* 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. | Other | Treatment Group |
| Conventional PhysiotherapyFor control group there will be aerobic exercise recommendation and resistive exercises focused on upper extremity. | Other | Control Group |
Primary outcome
Proprioception
Time frame: From enrollment to the end of treatment at 12 weeks, and at 6th week
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.
Dexterity
Time frame: From enrollment to the end of treatment at 12 weeks, and at 6th week
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.
Functionality
Time frame: From enrollment to the end of treatment at 12 weeks, and at 6th week
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.
7 secondary outcomes
Grip strength
Time frame: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Pinch strength
Time frame: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Neuropathic pain
Time frame: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Sensations
Time frame: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Hand muscles viscoelastic properties
Time frame: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Depression level
Time frame: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
Anxiety level
Time frame: From enrollment to at the end of treatment at 12 weeks, and at the 6th week
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 4 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Zeynep I BULUT, Mac principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Conventional Physiotherapy in people with Diabetes Mellitus Type 2, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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 4 Mar 2024. 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 Turkey (Türkiye). 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?
Proprioception (time frame: From enrollment to the end of treatment at 12 weeks, and at 6th week). 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 4 Mar 2024.