Clinical trial NCT03248206: Home-based Proprioceptive Neuromuscular Facilitation for Subjects With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Exercise
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of Nerve conduction study (NCS) at 12 weeks
timeFrame: pre-intervention (week 0) and follow-up evaluation (week 24)
measure: Change from baseline result of pinch-holding-up activity test at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of Purdue pegboard test at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of Minnesota Manual Dexterity Test at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of Manual tactile test at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary outcomes:
measure: Change from baseline result of Grasp and pinch power at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of pinch power at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of of shoulder flexion assessing by Micro FET hand-held dynamometer at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of shoulder internal rotation assessing by Micro FET hand-held dynamometer at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of shoulder external rotation assessing by Micro FET hand-held dynamometer at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of peak torque of shoulder external rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
measure: Change from baseline result of peak torque of shoulder internal rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
timeFrame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References: