Effectiveness of Virtual Bodily Illusion Intervention in Upper Limb Motor Function in People With Incomplete Spinal Cord Injury.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Valencia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Incomplete cervical spinal cord injury (AIS C, D or E).

Ability to understand instructions (Mini-Mental State Examination> 23 points)

Disqualifiers

Traumatic pathology in upper limbs.

Other alterations of the central nervous system or peripheral

Alterations in the vestibular system.

Concomitant diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Visual illusion

    Other intervention

    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

    Other intervention

    * 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

    Other intervention

    only the placebo visual illusion

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Visual Illusion (VI and therapeutic exercise program (EP)Experimental treatment 2 interventions
Group B: VI sham and EPSham comparator 2 interventions
Group C: VIExperimental treatment 1 intervention
Group D: VI shamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Range of motion of wrist

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.

Time frame
7 minutes.
2

Range of motion of elbow

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.

Time frame
7 minutes.
3

Fingers coordination.

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.

Time frame
7 minutes.
4

Rang of movement of gripper.

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.

Time frame
7 minutes.

Secondary outcomes

1

Quality of life index- Spinal cord injury

Total quality of life score, health and functioning subscale, social and economic subscale, psychological/spiritual subscale, and family subscale. The scales (satisfaction and importance) are on a 6-point Likert scale, ranging from 1, very dissatisfied (very unimportant), to 6, very satisfied (very important). Five scores are generated (i.e. total and 4 domains) on a 0 - 30 scale.

Time frame
8 minutes
2

Independence

The spinal cord independence measure (SCIM) was used. Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence. Each subscale score is evaluated within the 100-point scale (self-care: 0-20; respiration and sphincter management: 0-40; mobility: 0-40).

Time frame
5 minutes
3

Press force (Newtons)

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.

Time frame
7 minutes
4

Propioception

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 with close eyes, reproducing an exercise pretrained.

Time frame
5 minutes

Other outcomes

Sponsors and contacts

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