- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01453868
The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis (NIA)
The Effects of Neuromuscular Training on Balance in Patients With Multiple Sclerosis
Standing Balance, with and without blindfold, will be measured on patients with Multiple Sclerosis using a Biodex Balance Scale.
A Twelve week intervention with one non impact aerobics group and one control group will be performed.
Standing balance will then be retested on all subjects and the results will be statistically compared.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Standing Balance will be tested in 4 phases:
- On a firm surface eyes open
- On a frim surface eyes blindfolded
- On a foam surface eyes open
- On a foam surface eyes blindfolded
The aerobics classes will be conducted by a NIA (Non Impact Aerobics) instructor and will be a combination of tai chi, slow movement dancing, stretching and modified yoga stretches.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
-
-
Michigan
-
Gaylord, Michigan, Forenede Stater, 49735
- Rekruttering
- HealthZone Chiropractic Clinic
-
Kontakt:
- Donovan Adendorf, DC
- Telefonnummer: 989-731-2948
- E-mail: adendorf@msn.com
-
Kontakt:
- Donovan Adendorf, DC
- Telefonnummer: 989-732 1533
- E-mail: adendorff@hotmail.com
-
Ledende efterforsker:
- Donovan Adendorf, DC
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients that were diagnosed by a neurologist with Relapsing Remitting Multiple Sclerosis.
- EDSS scale between 1 and 6.
- Patients that are able to travel to and from a 12 week program location.
Exclusion Criteria:
- Patients that were diagnosed by a neurologist with primary or secondary progressive multiple sclerosis.
- EDSS scale above 6
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Active non impact aerobics
This group will be performing a 12 week non impact aerobics program twice a week.
|
a 12 week, twice a week class in non impact aerobics
Andre navne:
|
Aktiv komparator: Control group: Passive lecture series
The control group will also be measured for balance and then attend a 12 week lecture series with no exercise.
They will then also be remeasured post lectures series
|
a 12 week, once a week for one hour lecture series with no exercise.
Topics will cover symptom management in Multiple Sclerosis
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Biodex Scale Balance score: Automated
Tidsramme: Change: baseline and 12 weeks
|
A patient will step up to a Biodex Balance scale and will be instructed to try and maintain balance on the machine until it produces an automated outcome score for balance.
This number is directly related to a fall risk score in patients with neurological compromise.
|
Change: baseline and 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pre and post intervention questionaire
Tidsramme: Change: baseline and 12 weeks
|
A fifty question questionaire will be administered pre and post intervention.
These questions will focus on mood changes, attitude changes and overall quality of life changes related to adding exercise in their daily living.
|
Change: baseline and 12 weeks
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Donovan Adendorf, DC, Nelson Mandela Metropole University, Department of Health Sciences
- Studieleder: Rosa DuRandt, PhD, Professor: Human Movement Sciences, NMMU-Port Elizabeth South Africa
- Studiestol: Maryna Baard, PhD, Faculty of Helath Sciences-NMMU, Port Elizabeth South Africa
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H11-HEA-HMS-002
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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