Long-Term Effects of Torso-Weighting (TWPS)
tiistai 9. lokakuuta 2018 päivittänyt: San Francisco State University
Long-Term Effects of Balance-Based Torso-Weighting: Pilot Study
The goal of this pilot study is to test the protocol for investigating the longer-term effects of torso weighting on physical activity, number of falls, and muscle activation (when muscles turn on and off and how intensely) in five volunteers with multiple sclerosis.
The hypotheses of this study include: torso weighting will (1) increase physical activity, (2) decrease the number of falls, and (3) improve the timing and coordination of muscle activation during balance perturbations.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Torso weighting, using the balance-based torso-weighting (BBTW) method, is an intervention that addresses balance by first challenging stability in standing using a series of perturbations (nudges) and resisted rotations to people.
Challenging stability allows the assessor to determine directional instability.
Once the direction of instability is determined, small weights are placed on a vest-like garment and retesting of balance occurs.
In this study, participants will be tested with no weights (NW), with sham weights (SW), and with BBTW weighting (WT).
Following non-weighted baseline assessment, participants will be randomly allocated into the sham weight condition or BBTW weight condition in a cross-over design.
The initial condition (NW) will last four weeks and the final two conditions (SW,WT) will last two weeks each.
Following each condition, outcome measures will be reassessed.
Throughout the study, participants will be asked to wear a commercially-available remote monitoring device (e.g., Fitbit Flex) and keep a daily log of physical activity and number of falls.
During the SW and WT conditions, participants will wear the assigned garment for 2-4 hours daily.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
5
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
California
-
Oakland, California, Yhdysvallat, 94609
- Samuel Merritt University, Motion Analysis Research Center
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- Self-reported a diagnosis of multiple sclerosis
- Self-reported mild or moderate gait or balance difficulties
- Living in the community rather than in a care facility
- Able to walk independently for at least one minute at a time with or without an assistive device
- No exacerbations within the past 2 months
- Able to get to the testing area and tolerate 2-3 hours of testing for each assessment occasion
- Willing to be nudged by a researcher when standing
Exclusion Criteria:
- Unable to comprehend and follow instructions in English
- Current diagnosis of other neurological disorders such as head injury, stroke, Parkinson disease, or other conditions that affect gait or balance (self-reported)
- Experiencing pain that could be exacerbated by external perturbation while standing
- History of skin reaction to adhesives
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Torso Weights then Sham Weights
No weights worn for 4 weeks. Garment with torso weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with sham weights for 2-4 hours daily for 2 weeks. Participants wear the Fitbit Flex throughout. |
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Muut nimet:
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
The garment is then taken by another investigator and the actual weights are replaced with sham weights.
Muut nimet:
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Muut nimet:
|
|
Kokeellinen: Sham Weights then Torso Weights
No weights worn for 4 weeks. Garment with sham weights worn 2-4 hours daily for 2 weeks. Then participants cross-over to wear garment with torso weights for 2-4 hours daily for 2 weeks. Participants wear the Fitbit Flex throughout. |
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Muut nimet:
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
The garment is then taken by another investigator and the actual weights are replaced with sham weights.
Muut nimet:
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Steps Per Day
Aikaikkuna: up to 8 weeks
|
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
|
up to 8 weeks
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Sensory Organization Test
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
balance tested during 6 conditions on Neuro-com forceplate and surround and reported as a composite score (across the six conditions), 0-100, with higher scores indicating better balance; measure reported reflects change in the composite score from the visit that initiates Torso-weighting (TW) or sham weights (SW) to the visit that concludes daily wearing of TW or SW
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Gait Velocity
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
As measured using instrumented gait mat.
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
Online self-report of perceived current movement ability and preferred movement ability.
The scores are reported in standardized logits, 0-6, where 6 is competitive level athletic movement.
The reported values are the average change in current movement ability from initiation of daily wear to after 2 weeks of daily wear of TW or SW.
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Activities-Specific Balance Confidence Scale
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
Self-report measure of perception of confidence under various balance challenges on a scale of 0-100 with 100 being fully confident that the individual can perform the listed balance challenge without falling.
Data reported reflect the difference in scores from initiation to the 2-week point after initiation of TW or SW.
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Multiple Sclerosis Impact Scale 29
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
Self-report measure of the impact of MS on activities and participation.
The scale is reported in a physical and psychological subscale, with higher numbers (out of 100) indicating worse impact of multiple sclerosis (MS) on function.
Data are reported as change from initiation of TW or SW to end of 2 weeks of daily wear.
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Multiple Sclerosis Walking Scale 12
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
Self-report measure of the effect of MS on walking ability.
Larger numbers out of 100 mean that MS limits walking much more.
Data are reported as change in score from initiation of TW or SW to the visit after 2 weeks of daily wear of TW or SW.
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Six-Minute Walk Test
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
distance participant walks in 6 minutes.
Larger numbers indicate more distance covered.
Data reported are the change in distance walked from initiation of TW or SW to after 2 weeks of daily wear.
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Stride Length
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
As measured using instrumented gait mat.
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Percent of Gait Cycle in Single Limb Support
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
As measured in percent (e.g., 0.35) of gait cycle spent on one limb using instrumented gait mat.
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Step Width
Aikaikkuna: change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
As measured using instrumented gait mat.
|
change from initiation to 2-weeks after initiation of daily wearing of TW or SW
|
|
Electromyography to Assess Muscle Activation
Aikaikkuna: Week 4, Week 6, Week 8
|
Recording of muscle activation during quiet and perturbed standing before and after intervention at weeks 4, 6, and 8. Average values with and without weighting during each visit.
|
Week 4, Week 6, Week 8
|
|
Number of Falls Recorded in 2 Weeks of Wear Time.
Aikaikkuna: count of number of falls recorded at the end of two weeks of wearing TW or SW
|
Daily log manually recorded by participant for the 2 weeks of wear time.
This is a descriptive measure recording the total count (number) of falls per arm.
|
count of number of falls recorded at the end of two weeks of wearing TW or SW
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Diane Allen, PhD, San Francisco State University
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Sunnuntai 1. marraskuuta 2015
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 1. toukokuuta 2016
Opintojen valmistuminen (Todellinen)
Keskiviikko 1. kesäkuuta 2016
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 7. lokakuuta 2015
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 18. huhtikuuta 2016
Ensimmäinen Lähetetty (Arvio)
Tiistai 19. huhtikuuta 2016
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 6. marraskuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 9. lokakuuta 2018
Viimeksi vahvistettu
Maanantai 1. lokakuuta 2018
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- X15-48a
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