An interventional study of exercises for diabetic peripheral neuropathy and Health education for diabetic foot care in Diabetic Peripheral Neuropathy, sponsored by Okayama University. Completed at 1 site in Japan. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2019-05-10.
Sponsored by Okayama University · Not applicable, Interventional, and Supportive care
Among 10 studies in Motor Activity with a site in Japan — 2 open to participants now, 2 under way, none of them phase 3. Motor Activity · Japan.
Among the 10 studies in Motor Activity with a site in Japan, this one is the only one that started in 2017, is one of 6 with no phase, and was the 5th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →2 of the 10 studies in Motor Activity with a site in Japan are open now. Recruiting first, the newest first:
Kansai Medical University · Sites in Japan
Chiba University · Sites in Japan
A study can be open while its sites in Japan have not opened yet or have stopped. Only those recruiting at a site in Japan →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 25 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2
First in 2003; this study’s year is marked. 1 started in 2017.
This study's enrollment of 121 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 146 across the 8 interventional studies, 3,105 across the 2 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
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3 of 10 have an industry lead sponsor. The 10 most frequent:
Okayama University is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Okayama University has 1 study filed under Motor Activity — fewer than ten, so there is no comparison to draw.
1 of the studies in Motor Activity with a site in Japan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07061665Chiba UniversityCities for Better Health Childhood Obesity Prevention Initiative in JAPAN | 2027-09 |
Among the 10 studies in Motor Activity with a site in Japan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Diabetic Peripheral Neuropathy (DPN) is the common complication seen in the diabetic patients. Moreover, it will lead to another complication as disabilities and difficulties in activities of daily living (ADL). Most of the intervention for diabetes and diabetic neuropathic patients are mostly focusing on the prevention of foot ulcer. Diabetic foot care can prevent only for diabetes-related foot ulcer and foot amputation. It cannot be reduced DPN and cannot be improved the activities of daily living of the patient with DPN. Moreover, there is the restriction of weight-bearing exercise on the recommendation of exercises for the patients with DPN. Therefore, exercise program which may be suitable for all the patients with DPN was introduced in this study to improve ADL and decrease the neuropathic symptoms in the diabetic patients.
Compliance with exercise or intervention is not only critical to get adherence but also for the long-term use of its. Easy to do exercise in the short duration which can able to do on their own in their home promote their compliance and adherence to the exercises. In this study, the effectiveness of exercises in the patients with diabetic peripheral neuropathy was examined to fulfill the requirement of exercises which is simple and can be done in a short time. The objective of the study is to examine the effectiveness of exercise in the patients with diabetic peripheral neuropathy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
three times daily exercises of hands and fingers exercises and foot exercises which last for 10 minutes in eight weeks, and health education about diabetic foot care
Other: exercises for diabetic peripheral neuropathy · Other: Health education for diabetic foot care
health education about diabetic foot care
Other: Health education for diabetic foot care
Hands, fingers, and foot exercises for diabetic peripheral neuropathy to improve activities of daily living, and decreases the signs and symptoms of DPN
Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.
Change in Activities of daily living (ADLs) after intervention, at follow-up
ADLs were measured by using Patient Neurotoxicity Questionnaire (PNQ).
Time frame: eight weeks after intervention, eight weeks follow-up
Change in signs of DPN after intervention, at follow-up
DPN was assessed by using monofilament (SMW), Touch-TestTM Sensory Evaluator 5 Pieces Hand Kit of North Coast Medical Inc.
Time frame: eight weeks after intervention, eight weeks follow-up
Change in signs of DPN after intervention, at follow-up
DPN was assessed by tuning fork vibration test.
Time frame: eight weeks after intervention, eight weeks follow-up
Change in strength of hand grip
Hand grip was measured in kilograms by using TTM original Dynamometer 100 kg.
Time frame: eight weeks after intervention, eight weeks follow-up
Change in strength of pinch force
Key (lateral pinch) was measured by the gold standard B\&L Engineering® Pinch Gauge 0-30 lb. in 1.0 lb.
Time frame: eight weeks after intervention, eight weeks follow-up
Change in walking speed
Timed Up and Go (TUG) test was to measure the duration for walking in seconds.
Time frame: eight weeks after intervention, eight weeks follow-up
Ran from Jun 2017 to primary completion in Oct 2017, 3 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 3 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Okayama University