- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01418976
Walking and Balance Post-TBI
25. april 2013 opdateret af: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
IMPROVING WALKING AND BALANCE IN VETERANS WITH TRAUMATIC BRAIN INJURY: A PILOT STUDY EXAMINING FEASIBILITY AND DOSAGE
This is a case series study evaluating the feasibility and dosage of Intensive Mobility Training (IMT).
Twelve participants with chronic, mild-to-moderate, Traumatic Brain Injury (TBI) causing significant locomotor impairment, who meet these specific criteria, will be recruited.
Location and nature of neural insult will be determined by multimodal Magnetic Resonance Imaging (MRI) exam.
All participants will receive 3 hours of rehabilitation per day for 20 days, focusing on gait and balance.
Locomotion and balance will be comprehensively tested prior to IMT, after 10 days of IMT, and then again after the full dose of IMT.
This study will determine the feasibility of this intervention in the population of TBI patients, allow an estimate of effect size and provide initial information on possible neural predictors of success.
Furthermore the investigators will be able to determine whether the dosage of 10 days is sufficient or whether significant improvements are made with 20 days of the intervention.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
11
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29208
- 921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- greater than 3 months post-TBI (as defined by INTRuST criteria) and no longer receiving care as an inpatient in a rehabilitation facility.
- the ability to follow simple three-step commands;
- the ability to communicate presence and location of pain;
- the ability to sit independently without back or arm support for five minutes;
- the ability to stand with support of a straight cane, quad cane, or walker for 2 minutes;
- the ability to walk 10 meters with maximum 1 person assisting;
- presence of motor deficits (determined by clinical assessment of paresis);
- age ≥ 18;
- ability to give consent or have a acceptable surrogate capable of giving consent on subject's behalf
Exclusion Criteria:
- unable to ambulate 500 feet prior to TBI;
- history of serious chronic obstructive pulmonary disease or oxygen dependence;
- severe weight bearing pain;
- lower-extremity amputation;
- non-healing ulcers on the lower-extremity;
- renal dialysis or end stage liver disease;
- legal blindness or severe visual impairment;
- severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10°, knee flexion Range of Motion < 90°, hip flexion contracture > 25°, and ankle plantar flexion contracture > 15°);
- history of deep venous thrombosis or pulmonary embolism within 6 months
- uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions;
- severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest;
- intracranial hemorrhage related to aneurysm rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded);
- history of severe uncontrolled seizure disorder;
- other neurological conditions such as multiple sclerosis or Parkinson's Disease;
- pain that is scored greater than 5 out of 10 on a visual analog scale;
- any factor contraindicative to MRI examination (e.g., cardiac pacemaker/ defibrillator, pregnancy, aneurysm clips, insulin pump, metal fragments in the body).
- any other health problems judged by their screening physician to put the client at significant risk of harm during the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intensive Mobility Training (IMT)
Intensive Mobility Training will be used as an intensive physical therapy intervention.
Participants will receive 3 hours per day for a 10 day session, be post-tested, and receive another 10 day session followed by two more testing sessions.
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Intensive Mobility Training will be used as an intensive physical therapy intervention.
Participants will receive 3 hours per day for a 10 day session, be post-tested, and receive another 10 day session followed by two more testing sessions.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility as measured by study completion.
Tidsramme: post-treatment (after 20-day intervention)
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Feasibility will be determined by the ratio of participants that complete the intervention.
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post-treatment (after 20-day intervention)
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Feasibility as measured by pain ratings.
Tidsramme: during 20-day intervention
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Feasibility will be determined by daily change in pain scores as measured using visual analog scales.
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during 20-day intervention
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Feasibility as measured by fatigue ratings.
Tidsramme: during 20-day intervention
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Feasibility will be determined by daily change in fatigue scores as measured using visual analog scales.
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during 20-day intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Efficacy as measured by improvements in gait and mobility.
Tidsramme: from pre- to post-treatment during 20-day intervention.
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Efficacy will be measured by improvements in mobility and gait as measured by the Dynamic Gait Index, Timed Up and Go, Six- Minute Walk, and Falls Efficacy Scale.
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from pre- to post-treatment during 20-day intervention.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Stacy Fritz, Ph.D., P.T., University of South Carolina
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2011
Primær færdiggørelse (Faktiske)
1. marts 2013
Studieafslutning (Faktiske)
1. marts 2013
Datoer for studieregistrering
Først indsendt
16. august 2011
Først indsendt, der opfyldte QC-kriterier
16. august 2011
Først opslået (Skøn)
17. august 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. april 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. april 2013
Sidst verificeret
1. april 2013
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INTRuST-Walking and Balance
- Pro00007596 (Anden identifikator: University of South Carolina IRB)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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