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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248206
• Other study ID #: A-ER-105-257
• Status: Completed
• Phase: N/A
• Start date: August 23, 2017
• Est. completion date: December 14, 2018

Study information

• Verified date: December 2018
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 14, 2018
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Exercise

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks	determine the touch-pressure threshold of the hands	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Primary	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	pre-intervention (week 0) and follow-up evaluation (week 24)
Primary	Change from baseline result of pinch-holding-up activity test at 12 weeks	sensorimotor control of a hand	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Primary	Change from baseline result of Purdue pegboard test at 12 weeks	determine fine fingertip dexterity	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Primary	Change from baseline result of Minnesota Manual Dexterity Test at 12 weeks	determine unilateral and bilateral gross motor coordination of upper extremity	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Primary	Change from baseline result of Manual tactile test at 12 weeks	determine active touching sensation	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary	Change from baseline result of Grasp and pinch power at 12 weeks	Grip strength of the hands will be assessed with a Jamar dynamometer	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary	Change from baseline result of pinch power at 12 weeks	Pinch power is measured with a pinch gauge	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary	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	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary	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	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary	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	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary	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	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary	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	pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)