Assessments and Interventions for Hand Neuropathy in DM

National Cheng-Kung University

Status: Completed

Conditions: Neuropathy, Diabetic; Diabetes Mellitus

Treatments: Other: Biofeedback training; Other: Home-based tendon gliding and resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT03847129

B-ER-103-328

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Biofeedback training group

Experimental group

Description:

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.

Treatment:

Other: Biofeedback training

Home-based training group

Active Comparator group

Description:

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.

Treatment:

Other: Home-based tendon gliding and resistance training

Control group

No Intervention group

Description:

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