- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02787759
Falls-based Training for Walking Post-Stroke (FBT)
Falls-based Training to Improve Balance and Mobility Post-Stroke
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
In 2009, the American Heart Association (AHA) reported that the incidence of hemiplegia in patients six months post-stroke and over 65 years of age was 50%. Stroke survivors with chronic hemiplegia are at an increased risk for falling due to poor motor control, muscle weakness, and balance problems. While over-ground walking training has been shown to improve muscle coordination and functional movement outcomes in stroke survivors, the physical challenges to balance during the training is limited due to safety concerns. The limited training does not reflect the individuals' natural environment, which studies have shown to contain hazards that put post-stroke individuals at greater risk of loss of balance and falls. Therefore, it is important for clinicians to safely implement challenging environmental-hazard tasks as a way to effect greater improvements in walking capability post-stroke.
The usage of body weight support (BWS) during treadmill training has been shown to improve walking speed, but without the context of real world hazards, individuals may not gain improvements in balance related tasks nor gain confidence in moving through hazardous environments. The purpose of this study is to introduce a novel, falls-based training (FBT) approach that will enable individuals to be challenged at high levels of balance and walking safely, using a new robotic device called the KineAssist®, and to determine its relative effects compared to traditional body weight support treadmill training (BWSTT). We hypothesize that like the standard BWSTT, the novel FBT will result in improved walking speed, greater 6 minute walking distance, and greater Berg Balance scores. We also hypothesize that FBT will result in greater gains than BWSTT after the training, with a greater difference 6 months after training. In addition to the walking tests and the Berg Balance scale, we will compare the outcomes of the Stroke Impact Scale (SIS), the Geriatric Depression Scale (GDS)SF-36 Health Survey, the Activities-Specific Balance Confidence (ABC) Scale, the K-9 task Balance test, and the Dynamic Gait Index (DGI).
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Community dwelling unilateral stroke survivors, aged 19 years or older, 4 months to 5 years post incident, residual hemiplegia, who are able to ambulate at least 14m with an assistive device or the assistance of one person, with receptive and expressive communication capability, approval of physician, and voluntarily provided informed consent.
Exclusion Criteria:
- Significant and acute medical conditions, amputations, spasticity management that included phenol block injections within 12 months or botulinum toxin injections within 4 months of the study, any cognition involvement that impairs the ability to follow directions for, and plans to move out of the area within the next year or no transportation to the study area.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Hands-Free Walking
Body-weight supported treadmill training
|
Walking on a treadmill at 60-80% maximum heart rate without holding onto anything
|
|
Experimentell: Challenge Based plus Hands-Free
9 different balance and locomotor challenges applied during walking while not holding onto anything
|
Walking on a treadmill at 60-80% maximum heart rate without holding onto anything under 9 different challenging conditions
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
10 m walk test
Tidsram: 6 weeks
|
6 weeks
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: David A Brown, PhD, University of Alabama at Birmingham
Publikationer och användbara länkar
Allmänna publikationer
- Graham SA, Roth EJ, Brown DA. Walking and balance outcomes for stroke survivors: a randomized clinical trial comparing body-weight-supported treadmill training with versus without challenging mobility skills. J Neuroeng Rehabil. 2018 Nov 1;15(1):92. doi: 10.1186/s12984-018-0442-3.
- Naidu A, Brown D, Roth E. A Challenge-Based Approach to Body Weight-Supported Treadmill Training Poststroke: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 May 3;7(5):e118. doi: 10.2196/resprot.9308.
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 (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- F120425008
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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