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Long-Term Effects of Torso-Weighting (TWPS)

9. oktober 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

5

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Oakland, California, Forenede Stater, 94609
        • Samuel Merritt University, Motion Analysis Research Center

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:

  • 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

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: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Torso Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Andre navne:
  • WT
Enhed: Sham Weights
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.
Andre navne:
  • SW
Enhed: Fitbit Flex
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Andre navne:
  • remote activity monitoring device
Eksperimentel: 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.
Enhed: Torso Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Andre navne:
  • WT
Enhed: Sham Weights
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.
Andre navne:
  • SW
Enhed: Fitbit Flex
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Andre navne:
  • remote activity monitoring device

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Steps Per Day
Tidsramme: up to 8 weeks
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
up to 8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensory Organization Test
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

San Francisco State University

Samarbejdspartnere

Samuel Merritt University

Efterforskere

  • Ledende efterforsker: Diane Allen, PhD, San Francisco State University

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. november 2015

Primær færdiggørelse (Faktiske)

1. maj 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

7. oktober 2015

Først indsendt, der opfyldte QC-kriterier

18. april 2016

Først opslået (Skøn)

19. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • X15-48a

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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