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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Exercise
• Intervention / Treatment: Behavioral: lifestyle changes

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng-Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2017
• Primary Completion (Actual): August 14, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A-ER-105-257

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No