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

Primary Purpose

Diabetes Mellitus, Exercise

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
lifestyle changes
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cheng-Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PNF exercise program group

PNF in conjunction with tendon gliding exercise group

Arm Description

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 . )

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.

Outcomes

Primary Outcome Measures

Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks
determine the touch-pressure threshold of the hands
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
Change from baseline result of pinch-holding-up activity test at 12 weeks
sensorimotor control of a hand
Change from baseline result of Purdue pegboard test at 12 weeks
determine fine fingertip dexterity
Change from baseline result of Minnesota Manual Dexterity Test at 12 weeks
determine unilateral and bilateral gross motor coordination of upper extremity
Change from baseline result of Manual tactile test at 12 weeks
determine active touching sensation

Secondary Outcome Measures

Change from baseline result of Grasp and pinch power at 12 weeks
Grip strength of the hands will be assessed with a Jamar dynamometer
Change from baseline result of pinch power at 12 weeks
Pinch power is measured with a pinch gauge
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
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
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
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
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

Full Information

First Posted
August 7, 2017
Last Updated
January 28, 2019
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03248206
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
August 14, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PNF exercise program group
Arm Type
Active Comparator
Arm Description
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 . )
Arm Title
PNF in conjunction with tendon gliding exercise group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle changes
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline result of Semmes-Weinstein monofilament (SWM) test at 12 weeks
Description
determine the touch-pressure threshold of the hands
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of Nerve conduction study (NCS) at 12 weeks
Description
determine nerve condition through detection of the amplitude of the sensory and motor nerve action potential
Time Frame
pre-intervention (week 0) and follow-up evaluation (week 24)
Title
Change from baseline result of pinch-holding-up activity test at 12 weeks
Description
sensorimotor control of a hand
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of Purdue pegboard test at 12 weeks
Description
determine fine fingertip dexterity
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of Minnesota Manual Dexterity Test at 12 weeks
Description
determine unilateral and bilateral gross motor coordination of upper extremity
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of Manual tactile test at 12 weeks
Description
determine active touching sensation
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Secondary Outcome Measure Information:
Title
Change from baseline result of Grasp and pinch power at 12 weeks
Description
Grip strength of the hands will be assessed with a Jamar dynamometer
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of pinch power at 12 weeks
Description
Pinch power is measured with a pinch gauge
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of of shoulder flexion assessing by Micro FET hand-held dynamometer at 12 weeks
Description
Peak force of shoulder flexion (N) will be measured
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of shoulder internal rotation assessing by Micro FET hand-held dynamometer at 12 weeks
Description
Peak force of shoulder internal rotation (N) will be measured
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of shoulder external rotation assessing by Micro FET hand-held dynamometer at 12 weeks
Description
Peak force of shoulder external rotation (N) will be measured
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of peak torque of shoulder external rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
Description
Peak torque of shoulder external rotation (N⋅m) will be obtained
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)
Title
Change from baseline result of peak torque of shoulder internal rotation assessing by Bi-planar isokinetic dynamometer (BID) at 12 weeks
Description
Peak torque (PT) of shoulder internal rotation (N⋅m) will be obtained
Time Frame
pre-intervention (week 0), post-intervention (week 12) and follow-up evaluation (week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

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

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