Assessments and Interventions for Hand Neuropathy in DM

NCT03847129 | Completed

• 1 other identifier: B-ER-103-328
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate the effects of task-based biofeedback training compared with home-based programs on sensorimotor function and quality of life for diabetic patients with neuropathic hands. The investigators hypothesize that the task-based biofeedback training might have significant effectiveness for restoration of sensory function, precision pinch performance, hand dexterity and life quality for patients with diabetic neuropathy.

Conditions

Diabetes Mellitus; Neuropathy, Diabetic

Outcome Measures

Primary Outcomes (14)

• The pinch-holding-up activity (PHUA) test

  For the PHUA test, the participants were asked to pinch and lift the pinch device, and the pinch force will be recorded during the task. The raw force value would be collected and transferred into specific parameters include: (1) FP\_Peak: the maximum pinch force during the lifting phase in the PHUA test; (2) FL\_Max: the maximum load force at the onset of maximum upward acceleration; (3) force ratio of FP\_Peak to FL\_Max; (4) percentage of maximal pinch strength: the FP\_Peak divided by the maximal static pinch strength as a percentage of maximum voluntary contraction are detected in the initial evaluation.

  Baseline

• The pinch-holding-up activity (PHUA) test

  For the PHUA test, the participants were asked to pinch and lift the pinch device, and the pinch force will be recorded during the task. The raw force value would be collected and transferred into specific parameters include: (1) FP\_Peak: the maximum pinch force during the lifting phase in the PHUA test; (2) FL\_Max: the maximum load force at the onset of maximum upward acceleration; (3) force ratio of FP\_Peak to FL\_Max; (4) percentage of maximal pinch strength: the FP\_Peak divided by the maximal static pinch strength as a percentage of maximum voluntary contraction are detected in the initial evaluation.

  6~8 weeks after intervention

• Semmes-Weinstein monofilament (SWM)

  A touch-pressure threshold test with 20 nylon filaments with varying degrees of thickness is conducted. The examiner presses the filament at a 90° angle against the skin until it bows. When the patient indicates a response, the result is recorded. The filament is labeled with a numerical marking, which is a log to the base ten of the force in tenths of a milligram. The threshold value is the finest filament to which the subject correctly responds.

  Baseline

• Semmes-Weinstein monofilament (SWM)

  A touch-pressure threshold test with 20 nylon filaments with varying degrees of thickness is conducted. The examiner presses the filament at a 90° angle against the skin until it bows. When the patient indicates a response, the result is recorded. The filament is labeled with a numerical marking, which is a log to the base ten of the force in tenths of a milligram. The threshold value is the finest filament to which the subject correctly responds.

  6~8 weeks after intervention

• Purdue Pegboard test

  The Purdue Pegboard test has high testing validity and reliability and has been broadly used to measure hand dexterity. The test comprises four subtests involving the ability of the subject to place pins in small holes with the dominant hand, non-dominant hand, and with both hands simultaneously, as well as performing an assembly task.

  Baseline

• Purdue Pegboard test

  The Purdue Pegboard test has high testing validity and reliability and has been broadly used to measure hand dexterity. The test comprises four subtests involving the ability of the subject to place pins in small holes with the dominant hand, non-dominant hand, and with both hands simultaneously, as well as performing an assembly task.

  6~8 weeks after intervention

• Michigan Hand Outcomes Questionnaire (MHQ)

  Michigan Hand Outcomes Questionnaire (MHQ), a hand-specific outcomes instrument, is sensitive to providing an understanding of clinical changes with patients' self-reports. The MHQ contains six dimensions with 37 hand-specific questions. Higher scores indicate better hand function, with the exception of the pain facet. The testing reliability of MHQ ranges from 0.81 to 0.97.

  Baseline

• Michigan Hand Outcomes Questionnaire (MHQ)

  Michigan Hand Outcomes Questionnaire (MHQ), a hand-specific outcomes instrument, is sensitive to providing an understanding of clinical changes with patients' self-reports. The MHQ contains six dimensions with 37 hand-specific questions. Higher scores indicate better hand function, with the exception of the pain facet. The testing reliability of MHQ ranges from 0.81 to 0.97.

  6~8 weeks after intervention

• Diabetes-39 (D-39)

  The Diabetes 39 (D-39) is a disease-specific questionnaire used to assess quality of life (QoL) in patients with diabetes. It contains of 39 questions regarding five dimensions, including energy and mobility, diabetes control, anxiety and worry, social and peer burden, and sexual functioning. Higher scores on all dimensions reveal a better QoL. The reliability of the Chinese version of the tool ranges from 0.82 to 0.93, and it also has good convergent and discriminant validity.

  Baseline

• Diabetes-39 (D-39)

  The Diabetes 39 (D-39) is a disease-specific questionnaire used to assess quality of life (QoL) in patients with diabetes. It contains of 39 questions regarding five dimensions, including energy and mobility, diabetes control, anxiety and worry, social and peer burden, and sexual functioning. Higher scores on all dimensions reveal a better QoL. The reliability of the Chinese version of the tool ranges from 0.82 to 0.93, and it also has good convergent and discriminant validity.

  6~8 weeks after intervention

• Moving two-point discrimination (M2PD) test

  The Moving two-point discrimination test which is used to detect the shortest distance between the points that the subjects can perceive are tools for tactile acuity measuring. Also,it measures the innervation density of slowly and quickly adapting nerve fibers, respectively, and their corresponding mechanoreceptors as well.

  Baseline

• Moving two-point discrimination (M2PD) test

  The Moving two-point discrimination test which is used to detect the shortest distance between the points that the subjects can perceive are tools for tactile acuity measuring. Also,it measures the innervation density of slowly and quickly adapting nerve fibers, respectively, and their corresponding mechanoreceptors as well.

  6~8 weeks after intervention

• Static two-point discrimination (S2PD) test

  The two-point discrimination test which is used to detect the shortest distance between the points that the subjects can perceive are tools for tactile acuity measuring.

  Baseline

• Static two-point discrimination (S2PD) test

  The two-point discrimination test which is used to detect the shortest distance between the points that the subjects can perceive are tools for tactile acuity measuring.

  6~8 weeks after intervention

Study Arms (3)

Biofeedback training group

EXPERIMENTAL

The participants in the biofeedback training group attend a 30 minute biofeedback protocol per session, two times a week for six to eight weeks that is also combined with the regular diabetic care treatment in the Occupational Therapy Room.

Other: Biofeedback training

Home-based training group

ACTIVE COMPARATOR

The participants in this group receive similar doses of home-based tendon gliding exercises and resistance training with an anti-stress ball for 30 minutes at a frequency of 2 times a week for 6 to 8 weeks, also combined with the regular diabetic care treatment.

Other: Home-based tendon gliding and resistance training

Control group

NO INTERVENTION

The participants in the control group receive only diabetes disease prevention consultation once and outcome assessments twice.

Interventions

Biofeedback training OTHER

Before the biofeedback training, the baseline pinch force detected from a pinch-holding-up activity is recorded to set the target level according to the baseline data. With the aim for improving the performance, a 94% peak force value detected at the baseline is set as the target threshold for the training. Each participant attends a 30-minute biofeedback protocol per session, two times a week for six to eight weeks. Once the pinch force value exceeds the target range, visual and auditory cues are provided to inform the subjects to modify the performance.

Biofeedback training group

Home-based tendon gliding and resistance training OTHER

The participants receive similar doses of home-based tendon gliding exercises and resistance training with an anti-stress ball for 30 minutes at a frequency of 2 times a week for 6 to 8 weeks, also combined with the regular diabetic care treatment. Six to eight telephone visits are carried out to remind the patients to comply with the exercise program during the training period.

Home-based training group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with clinically-defined type II DM who were diagnosed based on the 1997 American Diabetes Association criteria
• impaired in terms of force modulation in precision pinch performance as detected using the PHUA test are referred from outpatients from the Department of Family Medicine in a medical center in southern Taiwan

You may not qualify if:

• diagnosed neuro-musculoskeletal disorders
• traumatic nerve injuries of the upper limbs
• trauma to the hand or congenital anomalies of the wrist and hand
• skin infections or disease of the hands
• cognitive deficits
• aged less than 20 years old

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 20, 2019
• Study Start: August 20, 2015
• Primary Completion: June 2, 2016
• Study Completion: June 2, 2016
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

TW (1)