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Completed

NCT Number: NCT03847129

Assessments and Interventions for Hand Neuropathy in DM

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.

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Key information

Conditions

Diabetes Mellitus Diabetes Complications Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Neuropathy, Diabetic Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University

Tainan, 701, Taiwan

About this study

Hand tendon gliding exercises allow both the flexor digitorum profundus and superficialis tendons of hands to achieve the greatest range of motion. Thus, in conjunction with resistive exercises for diabetic hands, such exercises are considered an appropriate home-based training method that has positive effects on various diabetic hand problems in terms of regaining smooth tendon excursion, preventing joint contracture, and reducing intrinsic muscle tightness. Different from the biomechanical approach to deal with hand problems, a biofeedback system can be used to provide real-time information on improper movements during task-based training intended to enhance either performance quality or accuracy. This study aims to analyze the difference in treatment effects between a computerized evaluation and a re-education biofeedback system that provides interactive sensorimotor information to shape the optimized coordinated pinch pattern of a hand and a home-based tendon gliding exercise program in conjunction with resistive exercise with weekly supervision on sensorimotor function and quality of life for diabetic patients. The investigators hypothesize the task-based biofeedback training using the biofeedback training system could have significant effectiveness for restoration of sensory function, precision pinch performance, hand dexterity and life quality for patients with diabetic neuropathy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(for training groups)

  • 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

Exclusion criteria

(for training groups and healthy control group)

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. The pinch-holding-up activity (PHUA) test

    Time frame: Baseline

    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.

  2. The pinch-holding-up activity (PHUA) test

    Time frame: 6~8 weeks after intervention

    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.

  3. Semmes-Weinstein monofilament (SWM)

    Time frame: Baseline

    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.

  4. Semmes-Weinstein monofilament (SWM)

    Time frame: 6~8 weeks after intervention

    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.

  5. Purdue Pegboard test

    Time frame: Baseline

    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. Purdue Pegboard test

    Time frame: 6~8 weeks after intervention

    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.

  7. Michigan Hand Outcomes Questionnaire (MHQ)

    Time frame: Baseline

    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.

  8. Michigan Hand Outcomes Questionnaire (MHQ)

    Time frame: 6~8 weeks after intervention

    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.

  9. Diabetes-39 (D-39)

    Time frame: Baseline

    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.

  10. Diabetes-39 (D-39)

    Time frame: 6~8 weeks after intervention

    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.

  11. Moving two-point discrimination (M2PD) test

    Time frame: Baseline

    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.

  12. Moving two-point discrimination (M2PD) test

    Time frame: 6~8 weeks after intervention

    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.

  13. Static two-point discrimination (S2PD) test

    Time frame: Baseline

    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.

  14. Static two-point discrimination (S2PD) test

    Time frame: 6~8 weeks after intervention

    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.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Functional Measurements and Therapeutic Intervention for Hand Neuropathy in Diabetes Mellitus

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 20, 2019
Registry last updated
Feb 20, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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