Diabetes MellitusNCT03248206
Home-based Proprioceptive Neuromuscular Facilitation for Subjects With Type 2 Diabetes Mellitus
A study testing lifestyle changes in people with Diabetes Mellitus and Exercise, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In this research work, the concept of strengthening technique of proprioceptive neuromuscular facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve neuromuscular function of upper extremity of patients with diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Exercise
- What is being tested?
- lifestyle changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Aug 2017to 14 Dec 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study participants will include clinically defined diabetic patients who are diagnosed based on the 1997 criteria of the American Diabetes Association. The inclusion criteria of the enrolled subjects are who suffered from neuropathy as diagnosed by abnormalities in either a nerve conduction study and / or quantitative sensory testing.
Who cannot join
- DM patients with (1) traumatic nerve injuries of the upper limbs, (2) trauma to the hand or congenital anomalies of the wrist and hand, (3) skin infections or disease, (4) known vascular complications of diabetes, such as stroke may have compromised the physical integrity of the patient, (5) grade 2 or higher arterial hypertension (>160/100 mmHg) or (6) cognitive deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Home-based Proprioceptive Neuromuscular Facilitation in Conjunction With Tendon Gliding Exercises on Sensorimotor Function in Upper Extremity of Subjects With Type 2 Diabetes Mellitus
In this research work, the concept of strengthening technique of proprioceptive neuromuscular facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve neuromuscular function of upper extremity of patients with diabetes mellitus. The first specific aim of the study is to examine the effects of home-based PNF exercise on the motor, sensation and functional performance parameters of upper extremity of the patients with diabetes mellitus. In addition, whether adding a tendon gliding exercise (TGE) to the home-based PNF exercises can provide better treatment effects for the patients with diabetes mellitus will also been investigated in this study. One of the hypothesis of this study is the prescribing home-based PNF exercise program has a positive treatment effect on neuromuscular function of the upper extremity of patients with diabetes mellitus. And,the other is home-based PNF in conjunction with TGE provides better benefits for neuromuscular function of the upper extremity of patients with diabetes mellitus.
- Conditions
- Diabetes Mellitus, Exercise
- Being tested
- lifestyle changes
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle changesBehavioural
Providing a home-based exercise program supervised by therapists can be an acceptable strategy with the characteristics of convenience and inexpensiveness to promote neuromuscular and functional component for the patients with diabetes mellitus.
| Study group | Role | What they receive |
|---|---|---|
| PNF exercise program group | Active comparator | The PNF home-program exercise group: perform grade 1\&2 two times a day, at least 3 times per week, for 3 sets of 12 repetitions to increase neuromuscular and musculoskeletal endurance. (Grade 1: The participants performs the diagonal- spiral pattern that will enhance the strength or movement of a targeted muscle or muscle group.; Grade 2:The participants performs PNF exercise with elastic bands . ) Receives: Behavioral: lifestyle changes |
| PNF in conjunction with tendon gliding exercise group | Experimental | Patients in PNF in conjunction with TGE group will perform PNF grade 1\&2 as well as tendon gliding exercise two times a day, at least 3 times per week, for 3 sets of 10 repetitions. Training duration for both the two groups is twelve weeks. Receives: Behavioral: lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks
determine the touch-pressure threshold of the hands
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of Nerve conduction study (NCS) at 12 weeks
determine nerve condition through detection of the amplitude of the sensory and motor nerve action potential
Measured: pre-intervention (week 0) and follow-up evaluation (week 24)
Change from baseline result of pinch-holding-up activity test at 12 weeks
sensorimotor control of a hand
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of Purdue pegboard test at 12 weeks
determine fine fingertip dexterity
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of Minnesota Manual Dexterity Test at 12 weeks
determine unilateral and bilateral gross motor coordination of upper extremity
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of Manual tactile test at 12 weeks
determine active touching sensation
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary outcomes (7)
Change from baseline result of Grasp and pinch power at 12 weeks
Grip strength of the hands will be assessed with a Jamar dynamometer
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of pinch power at 12 weeks
Pinch power is measured with a pinch gauge
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of of shoulder flexion assessing by Micro FET hand-held dynamometer at 12 weeks
Peak force of shoulder flexion (N) will be measured
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of shoulder internal rotation assessing by Micro FET hand-held dynamometer at 12 weeks
Peak force of shoulder internal rotation (N) will be measured
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of shoulder external rotation assessing by Micro FET hand-held dynamometer at 12 weeks
Peak force of shoulder external rotation (N) will be measured
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of peak torque of shoulder external rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
Peak torque of shoulder external rotation (N⋅m) will be obtained
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of peak torque of shoulder internal rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
Peak torque (PT) of shoulder internal rotation (N⋅m) will be obtained
Measured: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start23 Aug 2017
- Primary completion14 Aug 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248206
- Sponsor's protocol ID
- A-ER-105-257
- Status last verified
- Dec 2018
- First submitted
- 7 Aug 2017
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home-based Proprioceptive Neuromuscular Facilitation in Conjunction With Tendon Gliding Exercises on Sensorimotor Function in Upper Extremity of Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03248206
- Acronym / sponsor ID
- A-ER-105-257
- Conditions
- Diabetes Mellitus, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 14 Aug 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 14 Aug 2017 (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.
In this research work, the concept of strengthening technique of proprioceptive neuromuscular facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve neuromuscular function of upper extremity of patients with diabetes mellitus. The first specific aim of the study is to examine the effects of home-based PNF exercise on the motor, sensation and functional performance parameters of upper extremity of the patients with diabetes mellitus. In addition, whether adding a tendon gliding exercise (TGE) to the home-based PNF exercises can provide better treatment effects for the patients with diabetes mellitus will also been investigated in this study. One of the hypothesis of this study is the prescribing home-based PNF exercise program has a positive treatment effect on neuromuscular function of the upper extremity of patients with diabetes mellitus. And,the other is home-based PNF in conjunction with TGE provides better benefits for neuromuscular function of the upper extremity of patients with diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF exercise program group | Active comparator | Behavioral: lifestyle changesThe PNF home-program exercise group: perform grade 1\&2 two times a day, at least 3 times per week, for 3 sets of 12 repetitions to increase neuromuscular and musculoskeletal endurance. (Grade 1: The participants performs the diagonal- spiral pattern that will enhance the strength or movement of a targeted muscle or muscle group.; Grade 2:The participants performs PNF exercise with elastic bands . ) |
| PNF in conjunction with tendon gliding exercise group | Experimental | Behavioral: lifestyle changesPatients in PNF in conjunction with TGE group will perform PNF grade 1\&2 as well as tendon gliding exercise two times a day, at least 3 times per week, for 3 sets of 10 repetitions. Training duration for both the two groups is twelve weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study participants will include clinically defined diabetic patients who are diagnosed based on the 1997 criteria of the American Diabetes Association. The inclusion criteria of the enrolled subjects are who suffered from neuropathy as diagnosed by abnormalities in either a nerve conduction study and / or quantitative sensory testing.
Key exclusion criteria (1 listed)
- DM patients with (1) traumatic nerve injuries of the upper limbs, (2) trauma to the hand or congenital anomalies of the wrist and hand, (3) skin infections or disease, (4) known vascular complications of diabetes, such as stroke may have compromised the physical integrity of the patient, (5) grade 2 or higher arterial hypertension (>160/100 mmHg) or (6) cognitive deficits
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 |
|---|---|---|
| lifestyle changesProviding a home-based exercise program supervised by therapists can be an acceptable strategy with the characteristics of convenience and inexpensiveness to promote neuromuscular and functional component for the patients with diabetes mellitus. | Behavioural | PNF exercise program group, PNF in conjunction with tendon gliding exercise group |
Primary outcome
Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
determine the touch-pressure threshold of the hands
Change from baseline result of Nerve conduction study (NCS) at 12 weeks
Time frame: pre-intervention (week 0) and follow-up evaluation (week 24)
determine nerve condition through detection of the amplitude of the sensory and motor nerve action potential
Change from baseline result of pinch-holding-up activity test at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
sensorimotor control of a hand
Change from baseline result of Purdue pegboard test at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
determine fine fingertip dexterity
Change from baseline result of Minnesota Manual Dexterity Test at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
determine unilateral and bilateral gross motor coordination of upper extremity
Change from baseline result of Manual tactile test at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
determine active touching sensation
7 secondary outcomes
Change from baseline result of Grasp and pinch power at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of pinch power at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of of shoulder flexion assessing by Micro FET hand-held dynamometer at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of shoulder internal rotation assessing by Micro FET hand-held dynamometer at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of shoulder external rotation assessing by Micro FET hand-held dynamometer at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of peak torque of shoulder external rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Change from baseline result of peak torque of shoulder internal rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
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 30 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle changes in people with Diabetes Mellitus and Exercise, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 30 Jan 2019. 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 Taiwan. 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?
Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks (time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)). The study lists 6 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 30 Jan 2019.