- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07918339
Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis
This study is conducted to:
- Investigate the effect of virtual reality based training on balance and risk of falling.
- Investigate the effect of virtual reality based training on gait.
- Investigate the effect of mental practice on balance and risk of falling.
- Investigate the effect of mental practice on gait.
- Compare between the effect of virtual reality based training and mental practice on balance and gait
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Multiple sclerosis affects the central integration of sensory afferents that causes disturbance of balance, postural control and gait. Exercise interventions performed through VR applications encourage participants to engage in challenging tasks that integrate motor and cognitive demands, enhance patients' sensory processing and integration systems and allows them to receive information feedback and improve the motivation of training. Mental Practice is a complex cognitive operation that is possible thanks to the use of sensory and perceptive processes that allow an individual to reactivate specific motor actions in the working memory.
Purpose: This study is conducted to Investigate the effect of virtual reality based training on balance and risk of falling, Investigate the effect of virtual reality based training on gait, Investigate the effect of mental practice on balance and risk of falling, Investigate the effect of mental practice on gait and to compare between the effect of virtual reality based training and mental practice on balance and gait.
Methods: Fifty four patients of both sexes with relapsing remitting MS (RRMS). The patients will be diagnosed as having RRMS based on careful clinical examination by neurologist and diagnosis will be confirmed by radiological investigations as magnetic resonance imaging (MRI). Patients will be recruited from the outpatient clinic of Faculty of Physical Therapy, Pharos University in Alexandria and private clinics. Patients in this study will be randomly divided into three groups.
- Group (I) which will include 18 patients who will receive mental practice in addition to selected physical therapy .
- Group (II) which will include 18 patients who will receive virtual reality based training in addition to selected physical therapy.
- Group (III) which will include 18 patients who will receive selected physical therapy.
The treatment will be conducted 3 sessions per week for 6 weeks for 45 minutes.
Results: Data analysis with 2-way mixed Design MANOVA will be used to compare the groups for normally distributed data and Kruskal Wallis and Mann-Whitney tests will be used to compare the groups for non-parametric and not normally distributed data.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ola Z Asal, BSc
- Phone Number: 00201023830508
- Email: ola25jan@gmail.com
Study Contact Backup
- Name: Nagwa I Rehab, PhD
- Phone Number: 00201008124920
- Email: Nagwa1102010@yahoo.com
Study Locations
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypt
- Recruiting
- Faculty of Physical Therapy, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with RRMS.
- Patient's age will be range from 20 - 35 years..
- Patients are able to walk 10 meter with or without assistance.
- Patients with ≤ 6 according to an Expanded Disability Status Scale (EDSS).
- Patients are cognitively able to follow instructions.
- Patient's body mass index (BMI) will be ranged from 18.5 to 29.99 Kg/m2.
Exclusion Criteria:
- Patients with MS relapse in the last 30 days.
- Visual impairments interfering with VR.
- Severe spasticity or orthopaedic deformity.
- Recent musculoskeletal injury.
- History of epilepsy or motion sickness with VR.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality
|
The virtual environment presented via Head Mounted Display (HMD) has three-dimensional presentation and the panoramic view that covers the users' field of view, it facilitates immersion in the virtual and distraction from the real world |
|
Experimental: Mental Practice
|
Mental Practice is among the recommended strategies to enhance performance. MP is a symbolic exercise, involving repeated mental imagery in the absence of any visible muscle contraction. |
|
Experimental: Selected Physical Therapy Program
|
Dual tasking and Task oriented training in static and dynamic forms |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait
Time Frame: 6 weeks
|
spatial, temporal and angular parameters as cadence, step length and range of motion of hip, knee and ankle will be measured using software analysis "Kinovea" Kinovea is a free, open-source 2D video analysis software. It does not generate a single composite "score". Instead, it measures quantitative biomechanical and kinematic metrics from recorded video. |
6 weeks
|
|
Gait
Time Frame: 6 weeks
|
"10 minutes walk test" will be performed pre and post treatment by asking the patient to walk through a 12 meter walkway and calculate the time for 10 meters in tha walkway in two walking speeds( normal - fast) for 2 or 3 trials of each speed Speed > 1.2 m/s: Normal / Community AmbulatorAble to safely cross street intersections and navigate crowded environments. 0.8 - 1.2 m/s: Limited Community Ambulator/ Able to walk outdoors independently 0.4 - 0.8 m/s: Household Ambulator/ Mostly restricted to indoor walking; requires assistance or equipment outdoors. < 0.4 m/s: Severe Functional Limitation |
6 weeks
|
|
Balance
Time Frame: 6 weeks
|
static and dynamic balance will be assessed using "Berg Balance Scale" The Berg Balance Scale (BBS) is a 14-item clinical assessment scale designed to measure static balance and dynamic functional mobility, Point Scale: Each of the 14 tasks is rated on a 0 to 4 ordinal scale based on safety, independence, time held, or distance reached, Scores are summed across all items for a overall score ranging from 0 to 56 points (higher scores reflect better balance and mobility). |
6 weeks
|
|
Balance
Time Frame: 6 weeks
|
"Timed Up and Go" test giving numerical data pre and post treatment about balance and risk of falling Test is scored entirely by time (in seconds): Time < 10 seconds: Normal / Completely IndependentFreely mobile; minimal to no fall risk 10 - 19 seconds: Mostly Independent, Reasonable balance and gait speed, generally low fall risk 20 - 29 seconds: Variable MobilityImpaired mobility, slower gait speed > 30 seconds: Severely Impaired, high fall risk |
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nagwa I Rehab, PhD, Cairo University
- Study Director: Rania M Tawfik, PhD, Cairo University
- Study Director: Ebtesam M Fahmy, PhD, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006172
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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