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Completed

NCT Number: NCT03248206

Home-based Proprioceptive Neuromuscular Facilitation for 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.

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Key information

Conditions

Diabetes Mellitus Behavior Endocrine System Diseases Exercise Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Change from baseline result of Grasp and pinch power at 12 weeks

    Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

    Grip strength of the hands will be assessed with a Jamar dynamometer

  2. Change from baseline result of pinch power at 12 weeks

    Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

    Pinch power is measured with a pinch gauge

  3. Change from baseline result of of shoulder flexion assessing by Micro FET hand-held dynamometer at 12 weeks

    Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

    Peak force of shoulder flexion (N) will be measured

  4. Change from baseline result of shoulder internal rotation assessing by Micro FET hand-held dynamometer at 12 weeks

    Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

    Peak force of shoulder internal rotation (N) will be measured

  5. Change from baseline result of shoulder external rotation assessing by Micro FET hand-held dynamometer at 12 weeks

    Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

    Peak force of shoulder external rotation (N) will be measured

  6. Change from baseline result of peak torque of shoulder external rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks

    Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

    Peak torque of shoulder external rotation (N⋅m) will be obtained

  7. Change from baseline result of peak torque of shoulder internal rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks

    Time frame: pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

    Peak torque (PT) of shoulder internal rotation (N⋅m) will be obtained

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2017
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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