- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00223782
Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study suggests that teaching a new strategy is beneficial to decrease the forefoot peak plantar pressure in individuals who are susceptible to plantar ulcerations. It has not, however, been studied whether these changes would be maintained long-term or if they had any effect on the ulceration rate. Additionally, no analysis of the amount of visual feedback necessary to elicit the desired motor pattern was discussed. It has been suggested that proprioception plays an integral role in the use of feedback to develop error-detection mechanisms by integrating visual feedback and kinesthetic variables. In the diabetic peripheral neuropathy subject population, proprioception and kinesthesia may be compromised. This may have effects on the ability of this population to maintain changes in inappropriate movement patterns. A significant portion of patients continue to develop plantar ulcers even with prescriptive footwear compliance, so gait training to change inappropriate patterns which result in the high plantar pressures may be critical to prevent ulceration.
Comparisons: Two groups of subjects will receive gait training, one group will receive feedback of performance while the other will only receive training, and one control group. Comparisons will include whether plantar pressures are decreased in the training groups, and if those changes are maintained long-term.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
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West Los Angeles, California, Förenta staterna, 90073
- VA Greater Los Angeles Healthcare System, West LA
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Diagnosis of diabetes for at least one year.
- Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested (31;32)
- Age 50-80 years old
- Able to ambulate independently without assistive devices (e.g. walker or crutches) (8) for 30 feet.
- No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions
Exclusion Criteria:
- Other non-diabetic causes of neuropathy by history
- Symptomatic peripheral vascular disease
- Joint pain, swelling and/or limited of range of motion in the lower extremities that interfere with walking or exercise
- Visual problems not correctable with glasses or contact lens
Passive range of motion limitations are described as:
- Hip flexion < 1000;
- Hip extension < 200;
- Knee flexion < 1250;
- Knee extension < 00 (unable to obtain full extension);
- Ankle plantar flexion < 250;
- Ankle dorsiflexion < 150
- Other systemic or local diseases that could interfere with walking assessment
- Severe systemic diseases other than diabetes or its complications, especially those interfering with exercise tolerance
- Amputation in the lower extremities
- Terminal illness
- Severe obesity: BMI>30 kg/m2 (33)
- Severe foot deformities (e.g. flexion contracture of the toes, pes cavus, Charcot disease)
- Mini-mental status of <27 or diagnosis of dementia
- History of alcohol or drug abuse
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: 1
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Plantar Pressure
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Karen Perell, PhD RKT, VA Greater Los Angeles Healthcare System, West LA
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- A3117R
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-
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