- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00223782
Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
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West Los Angeles, California, Forenede Stater, 90073
- VA Greater Los Angeles Healthcare System, West LA
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 1
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Plantar Pressure
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Karen Perell, PhD RKT, VA Greater Los Angeles Healthcare System, West LA
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A3117R
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