Long-Term Effects of Torso-Weighting (TWPS)
9. oktober 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
5
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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California
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Oakland, California, Forente stater, 94609
- Samuel Merritt University, Motion Analysis Research Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
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 navn:
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
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 navn:
Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
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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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Diane Allen, PhD, San Francisco State University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2015
Primær fullføring (Faktiske)
1. mai 2016
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
7. oktober 2015
Først innsendt som oppfylte QC-kriteriene
18. april 2016
Først lagt ut (Anslag)
19. april 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. november 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. oktober 2018
Sist bekreftet
1. oktober 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- X15-48a
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