CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Without haptic stimulationWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug111 Acceptability questionnaire Wiki 1.00
drug1036 Haptic stimulation Wiki 1.00
drug1662 Observation of Virtual Actions (step 4) Wiki 1.00
drug1791 Performing Virtual Actions Wiki 1.00
drug1661 Observation of Virtual Actions Wiki 1.00
drug2063 Relaxation Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D010291 Paresis NIH 1.00

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001269 Hemiparesis HPO 1.00

There is one clinical trial.

Clinical Trials


1 VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness

After a hospitalization in Intensive Care Unit (ICU), approximately 50% of patients usually have a ICU-Weakness, i.e. nerves and muscles injury secondary to immobilization and to treatments which had to be used. This disease is expected to be similar or even higher in patients suffering from COVID-19 and hospitalized in ICU due to the average length of hospitalization of several weeks in this population. This condition will delay the return-to-walk of these patients, their discharge from hospitalization and may deteriorate their autonomy in daily life activities. Virtual Reality (VR) environments are already used and have proven their worth for the assessment and rehabilitation of patients with neurological diseases. It therefore seems appropriate to offer the use of virtual environments for this type of population. VR represents a unique opportunity for the rehabilitation care of these patients, and in particular those who have been reached by COVID-19, due to the possible mismatch between the amount of motor rehabilitation to be provided and the fatigability and breathlessness at the slightest effort which seem particularly intense in this population. The main objective of our project is to improve and to accelerate gait recovery in patients hospitalized in Physical and Rehabilitation Medicine after discharge from Resuscitation or Continuous Care Unit and in patients hospitalized in ICU and presenting ICU-weakness secondary to resuscitation, notably due to COVID-19 infection, thanks to the use of Virtual Reality tools. The VR tool will consist of virtual environments presented using a Virtual Reality headset where an avatar (double) of the patient hospitalized in Physical and Rehabilitation Medicine or in ICU will be represented, who will perform different motor tasks involving their lower limbs (ex: walking, or kicking a ball) in several different virtual environments (settings). The patient will be asked to observe actions, then to imagine carrying out their actions which will be performed by the avatar in the virtual environment, then they will be able to control the actions of the avatar using their legs thanks to sensors, then feel walking sensations through the use of haptic devices.

NCT04441164 Weakness of the Lower Limbs Other: Observation of Virtual Actions Other: Relaxation Other: Acceptability questionnaire Other: Observation of Virtual Actions (step 4) Other: Performing Virtual Actions Other: Haptic stimulation Other: Without haptic stimulation
MeSH:Muscle Weakness Paresis
HPO:Hemiparesis

Primary Outcomes

Description: Number of meters taken during the 6-minute test the day after the last session.

Measure: 6-minute test

Time: Day 10

Secondary Outcomes

Description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 10-meter test (time in seconds)

Measure: Time for 10-meter test

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: 6-minute walk test (need for breaks, scale de Borg, existence of desaturation)

Measure: 6-minute walk test

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Gait assessment before the start of the first session, the day after the last session and 1 month from inclusion: recovery time for walking over 10 meters without human or technical assistance

Measure: Recovery time

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: normal or deficient posture balance in sitting and standing

Measure: Normal or deficient posture balance in sitting and standing

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Berg Balance Scale. Berg's balance scale includes 14 tests that assess static balance and dynamic balance. Each test is rated from 0 (needs help) to 4 (can do on him/her own). Total score is on 56 points.

Measure: Berg Balance Scale

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: Timed Up and Go test (time in seconds)

Measure: Timed Up and Go test

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of balance before the start of the first session, the day after the last session and 1 month from inclusion: test of the 10 chair lifts (duration in seconds, existence of a desaturation, Borg scale)

Measure: Duration for the test of the 10 chair lifts

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Strength assessment before the start of the first session, the day after the last session and within 1 month of inclusion: MRC testing of the lower limbs. The Medical Research Council's scale (MRC scale) is an assessment of muscle power, rated form 0 (no contraction) to 5 (normal power).

Measure: MRC scale

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Assessment of autonomy before the start of the first session, the day after the last session and within 1 month of inclusion: Functional Independence Measure. The Functional Independence Measure (FIM) is an 18-item instrument measuring a person's level of disability in terms of burden of care. Each item is rated from 1 (requiring total assistance) to 7 (completely independent). Three independent FIM scores can be generated by summing item scores: a total score (FIM total: 18 items), a motor score (FIM motor: eating, grooming, bathing, dressing - upper body, dressing - lower body, toileting, bladder management, bowel management, and transfers bed/chair/wheelchair, toilet, tub/shower, walk, stairs), and a cognitive score (FIM cognitive: auditory comprehension, verbal expression, social interaction, problem solving, and memory). Multiple studies support the reliability and validity of FIM scales in the older population.

Measure: Functional Independence Measure

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion

Description: Acceptability (a priori, patients and caregivers for stage 2) questionnaires

Measure: Acceptability

Time: Day 1 (step 2)

Description: Acceptance (patients for stages 1, 3, 4 and 5) questionnaires

Measure: Acceptance

Time: Day 1 (step 2)

Description: Fatigue assessment (visual analog scale) (steps 1, 3, 4, 5)

Measure: Fatigue

Time: End of each session, at days 1 to 9

Description: Collections of possible undesirable effects by open question at the end of each session with the Virtual Reality tool (steps 1, 3, 4, 5)

Measure: Undesirable effects

Time: End of each session, at days 1 to 9

Description: Assessment of confidence in the future using a questionnaire (steps 1, 3, 4, 5) before the start of the first session, the day after the last session and 1 month from inclusion

Measure: Confidence in the future

Time: Before the start of the first session (day 1), the day after the last session (day 9) and 1 month after inclusion


Related HPO nodes (Using clinical trials)