Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Home-based Proprioceptive Neuromuscular Facilitation for Subjects With Type 2 Diabetes Mellitus

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: NCT03248206
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Exercise Behavioral: lifestyle changes Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 23, 2017
Actual Primary Completion Date : August 14, 2018
Actual Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PNF exercise program group
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 . )
Behavioral: lifestyle changes
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.

Experimental: PNF in conjunction with tendon gliding exercise group
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.
Behavioral: lifestyle changes
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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) ]
    Grip strength of the hands will be assessed with a Jamar dynamometer

  2. 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) ]
    Pinch power is measured with a pinch gauge

  3. 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) ]
    Peak force of shoulder flexion (N) will be measured

  4. 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) ]
    Peak force of shoulder internal rotation (N) will be measured

  5. 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) ]
    Peak force of shoulder external rotation (N) will be measured

  6. 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) ]
    Peak torque of shoulder external rotation (N⋅m) will be obtained

  7. 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) ]
    Peak torque (PT) of shoulder internal rotation (N⋅m) will be obtained



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:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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): NCT03248206


Locations
Layout table for location information
Taiwan
National Cheng-Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital
Layout table for additonal information
Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT03248206    
Other Study ID Numbers: A-ER-105-257
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases