Clinical trial NCT03847129: Assessments and Interventions for Hand Neuropathy in DM
Official title: Functional Measurements and Therapeutic Intervention for Hand Neuropathy in Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Neuropathy, Diabetic
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The pinch-holding-up activity (PHUA) test
timeFrame: Baseline
measure: The pinch-holding-up activity (PHUA) test
timeFrame: 6~8 weeks after intervention
measure: Semmes-Weinstein monofilament (SWM)
timeFrame: Baseline
measure: Semmes-Weinstein monofilament (SWM)
timeFrame: 6~8 weeks after intervention
measure: Purdue Pegboard test
timeFrame: Baseline
measure: Purdue Pegboard test
timeFrame: 6~8 weeks after intervention
measure: Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: Baseline
measure: Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: 6~8 weeks after intervention
measure: Diabetes-39 (D-39)
timeFrame: Baseline
measure: Diabetes-39 (D-39)
timeFrame: 6~8 weeks after intervention
measure: Moving two-point discrimination (M2PD) test
timeFrame: Baseline
measure: Moving two-point discrimination (M2PD) test
timeFrame: 6~8 weeks after intervention
measure: Static two-point discrimination (S2PD) test
timeFrame: Baseline
measure: Static two-point discrimination (S2PD) test
timeFrame: 6~8 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
References: