Effectiveness of Virtual Bodily Illusion Intervention in Upper Limb Motor Function in People With Incomplete Spinal Cord Injury.
Condition(s) studied
Investigational drug(s) / intervention(s)
Visual illusion: the patient will be seated in a chair with a table in front of it. The front part of the trunk will be covered with a black blanket that will be attached to the table. On the table, you will see arms and hands projected performing different types of functional manual activities that will include mobility and strength tasks. The projected arms will be adapted to the dimensions of each subject so that the patient can recognize the projected arms as theirs. This program will last 10 minutes.
Physical exercise: * General mobility and warm-up: flexion-extension joint movements, rotations, deviations, abduction-adduction, etc. * Gross mobility and coordination: ball games. * Fine mobility and coordination: writing tasks, puzzles, abacus ... * Strength exercises: shoulder, elbow, wrist, fingers. * Stretching.
Sham Visual illusion: only the placebo visual illusion
Study summary
Previous studies have shown that the neuroplasticity of the residual corticospinal fibers, the motor cortex and the spinal neurons plays an important role in the spontaneous functional recovery of people with neurological or musculoskeletal pathology. However, it is also possible to stimulate the neuroplasticity mechanisms of these structures through techniques aimed at rehabilitating different deficits (for example, motor function or sensitivity). In general, intervention programs are usually carried out, in most cases, using low-cost strategies such as therapeutic physical exercise programs.
The objective of this study is to analyze the effectiveness of visual illusion therapies in combination with conventional exercises on the symptoms and signs related to incomplete spinal cord injury that affects the upper limb.
The study will include the realization of three measurements that will be carried out one day before starting the program, one day after finishing it, and one month later (follow-up).
The clinical assessment will be composed of the study of the following variables: Motor function and motor skills, Upper limb isometric force, Muscle activation, Muscle tone, Quality of life, Functionality. All interventions will last eight weeks and will be planned according to the availability of volunteers. In each session, it will be recorded if any type of adverse effect occurs. There will be four types of interventions: i. Visual Illusion (IV) and therapeutic exercise program (PE), ii.placebo and PE, iii. IV, iv. IV placebo.
Eligibility
Primary outcome measure(s)
- Range of motion of wrist — 7 minutes.
Nedcodo Agile was used to assess this outcome. Nedcodo Agile is a newly developed tool by Institut de Biomecànica de València (IBV) that measures elbow and wrist range of movement in degrees of range of movement, and press force in newtons. - Range of motion of elbow — 7 minutes.
Nedcodo Agile was used to assess this outcome. Nedcodo Agile is a newly developed tool by Institut de Biomecànica de València (IBV) that measures elbow and wrist range of movement in degrees of range of movement, and press force in newtons. - Fingers coordination. — 7 minutes.
Hand assessment tablet app is a tool developed by Neurorehabilitation and Brain research group that assesses hand coordination and dexterity. This app counts the number of taps in a determined time and their velocity. - Rang of movement of gripper. — 7 minutes.
Hand assessment tablet app is a tool developed by Neurorehabilitation and Brain research group that assesses hand coordination and dexterity. This app measure the range of gripper of each finger. - Graphomotricity. — 7 minutes.
Hand assessment tablet app is a tool developed by Neurorehabilitation and Brain research group that assesses hand coordination and dexterity. This app measure the error in centimeters of graphomotricity activity. - Upper limb isometric force. — 10 minutes
A load cell (CTCS; Mutronic) is used to assess upper limb muscles force (in Newtons). - Muscle activation. — 10 minutes.
The BTS FreeEMG Electromyograph is used to assess upper limb muscles activation (in microV). - Severity of pain and degree of interference with feeling and function. — 5 minutes
Brief Pain Inventory is used to assess neuropathic pain. This test measures pain severity and pain interference from 0 to 10. - Muscle tone of upper limb. Natural Oscillation Frequency. — 5 minutes
MyotonPRO is used to assess tone or state of tension (Natural Oscillation Frequency \[Hz\]) of upper limb muscles. - Muscle tone of upper limb. Biomaechanical properties. — 5 minutes
MyotonPRO is used to assess biomaechanical properties (Dynamic Stiffness \[N/m\], Logarithmic Decrement of natural oscillation, characterizing and Elasticity) of upper limb muscles. - Muscle tone of upper limb. Viscoelastic properties — 5 minutes
MyotonPRO is used to assess viscoelastic properties (Mechanical Stress Relaxation Time \[ms\], Ratio of deformation and Relaxation time, characterising Creep (Deborah number)) of upper limb muscles. - Spasticity of upper limb — 2 minutes
Modified Ashworth Scale (from 1 to 4): 0: No increase in muscle tone. 1: Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension. 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion. 2: A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved. 3: Considerable increase in muscle tone, passive movement difficult. 4: Affected part(s) rigid in flexion or extension..
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Facultat de Fisioteràpia, Universitat de València | Valencia | Valencia | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05142943 on ClinicalTrials.gov ↗ ← All trials in Spain