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Clinical Trials/NCT03248206
NCT03248206
Completed
Not Applicable

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

National Cheng-Kung University Hospital1 site in 1 country12 target enrollmentAugust 23, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
National Cheng-Kung University Hospital
Enrollment
12
Locations
1
Primary Endpoint
Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2017
End Date
December 14, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 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

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

Secondary Outcomes

  • Change from baseline result of shoulder internal rotation assessing by Micro FET hand-held dynamometer at 12 weeks(pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24))
  • Change from baseline result of Grasp and pinch power at 12 weeks(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(pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24))
  • Change from baseline result of pinch power at 12 weeks(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(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(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(pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24))

Study Sites (1)

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