- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah International University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment
|
|
Actieve vergelijker: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Berg Balance scale
Tijdsspanne: 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
|
|
Time up and Go
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Muhammad Asif A Javed, MS, Riphah International University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REC/LHR/20/2054 Qandil Akram
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .