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Long-Term Effects of Torso-Weighting (TWPS)

9 oktober 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

5

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • Oakland, California, Verenigde Staten, 94609
        • Samuel Merritt University, Motion Analysis Research Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Torso Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Andere namen:
  • WT
Apparaat: 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.
Andere namen:
  • ZW
Apparaat: Fitbit Flex
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Andere namen:
  • remote activity monitoring device
Experimenteel: 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.
Apparaat: Torso Weights
Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
Andere namen:
  • WT
Apparaat: 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.
Andere namen:
  • ZW
Apparaat: Fitbit Flex
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Andere namen:
  • remote activity monitoring device

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Steps Per Day
Tijdsspanne: up to 8 weeks
Continuous activity data collection via commercially-available remote monitoring device and stored on server.
up to 8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sensory Organization Test
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

San Francisco State University

Medewerkers

Samuel Merritt University

Onderzoekers

  • Hoofdonderzoeker: Diane Allen, PhD, San Francisco State University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2015

Primaire voltooiing (Werkelijk)

1 mei 2016

Studie voltooiing (Werkelijk)

1 juni 2016

Studieregistratiedata

Eerst ingediend

7 oktober 2015

Eerst ingediend dat voldeed aan de QC-criteria

18 april 2016

Eerst geplaatst (Schatting)

19 april 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2018

Laatste update ingediend die voldeed aan QC-criteria

9 oktober 2018

Laatst geverifieerd

1 oktober 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • X15-48a

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