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

NCT03248206 | Completed

• 1 other identifier: A-ER-105-257
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Exercise

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• 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 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 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 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)

Study Arms (2)

PNF exercise program group

ACTIVE COMPARATOR

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

PNF in conjunction with tendon gliding exercise group

EXPERIMENTAL

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

Interventions

lifestyle changes BEHAVIORAL

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.

PNF exercise program group; PNF in conjunction with tendon gliding exercise group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 14, 2017
• Study Start: August 23, 2017
• Primary Completion: August 14, 2018
• Study Completion: December 14, 2018
• Last Updated: January 30, 2019

Record last verified: 2018-12

Locations

TW (1)