NCT03847129

Assessments and Interventions for Hand Neuropathy in DM

Functional Measurements and Therapeutic Intervention for Hand Neuropathy in Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus
• Neuropathy, Diabetic

Interventions

Type	Name	Description
OTHER	Biofeedback training	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.
OTHER	Home-based tendon gliding and resistance training	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.

Timeline

• Start date: 2015-08-20
• Primary completion: 2016-06-02
• Completion: 2016-06-02
• First posted: 2019-02-20
• Last updated: 2019-02-20

Locations

1 site across 1 country: Taiwan