Assessments and Interventions for Hand Neuropathy in DM
NCT ID: NCT03847129
Last Updated: 2019-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2015-08-20
2016-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Biofeedback training group
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.
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.
Home-based training group
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.
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.
Control group
The participants in the control group receive only diabetes disease prevention consultation once and outcome assessments twice.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion 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
* 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
20 Years
ALL
Yes
Sponsors
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National Cheng-Kung University Hospital
OTHER
Responsible Party
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Locations
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National Cheng-Kung University
Tainan City, , Taiwan
Countries
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Other Identifiers
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B-ER-103-328
Identifier Type: -
Identifier Source: org_study_id
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