- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04797598
Effects of Virtual Reality and Cyclic Training on Balance
Effects of Virtual Reality and Cyclic Training on Balance in Sub-acute Stroke
Stroke is the third leading cause of functional disability and death in the world. It leads to many problems that affect gait, upper extremity function and balance. In stroke patients balance dysfunction leads to impaired postural control and walking. Because of poor balance fall rate increases in stroke patients. Balance is an important predictor of outcome in stroke rehabilitation. After stroke difficulties in balance control may be caused by multiple factors such as muscle weakness, impaired proprioception, and asymmetry in weight wearing, spasticity and impaired motor control. Different means are used to treat stroke, some conventional treatments along with new adjunct therapies are usual practice for the rehabilitation of the stroke.
Virtual Reality is choice of adjunct therapy now a days and can be used in different ways for the rehabilitation. Virtual Reality or active video gaming proved their role as vital part of the treatment program in pediatric rehabilitation as well as adult rehabilitation program. These programs help the patient to achieve goals for functional and activities of daily living skills.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah International University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Sub-acute stroke
- Able to stand for 5 minutes
- The score of mini mental state examination (MMSE) > 19
- Male and Females (both genders)
- Verbal instructions can follow
Exclusion Criteria:
- Visual and auditory problem unable to hear and see feedback from the video game and problem of vestibular system
- Spasticity of lower limb
- Any other medical condition that could affect movement and balance
- Use of pacemaker, apraxia, epilepsy
- Psychiatric disorders
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Virtual Reality group
In this group patients will be treated with virtual reality .
This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24.
The virtual reality group will receive 30 minutes virtual reality training and 30 minutes conventional treatment.
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This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment
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Aktiv komparator: Cyclic training group
In this group patients will be treated with cyclic training .
This group will receive therapy session for 1 hour, two times in a week and for 12 weeks, total session will be 24.
The cyclic training group will receive 30 minutes cyclic training and 30 minutes conventional treatment
|
This will receive cyclic training session.
both group will receive conventional physical therapy as base line treatment
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Berg Balance scale
Tidsramme: 12 weeks
|
this tool is used for assessing change from baseline .14
item scale designed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.it is a 14 item scale list with each item consisting of a five point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level of function.
BBS have high validity and reliability of 0.98 41 -56= low fall risk 21-40 = medium fall risk 0-20 = high risk
|
12 weeks
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Time up and Go
Tidsramme: 12 weeks
|
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. Interpretation: ≤ 10 seconds = normal. ≤ 20 seconds = good mobility, can go out alone, mobile without gait aid. ≤ 30 seconds = problems, cannot go outside alone, requires gait aid. * A score of ≥ 14 seconds has been shown to indicate high risk of falls. |
12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Muhammad Asif A Javed, MS, Riphah International University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC/LHR/20/2054 Qandil Akram
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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