Clinical Trials

So far the clinical trials have shown that Gesture Therapy can induced motor dexterity improvements similar to that obtained with classical occupational therapy as measured with validated motor dexterity scales (Fugl-Meyer and Dexterity Index) [SucarLE2010a]. Importantly, it achieves this behavioural improvement evoking higher motivation from the patients (Intrinsic Motivation Inventory), although this requires further study. We have also explored how the observable improvements in motor dexterity arise at cortical level. Initial results suggests strong recruitment of cerebellar activity which has been suggested a sign of good prognosis. You can find more details in [OrihuelaEspinaF2011a].

Clinical Trials

  1. Trial I: 1st clinical evaluation on stroke patients at INNN (Completed)
    • 22 Adults in 2 groups (Control -Occupational Therapy- and Intervention -Gesture Therapy-).
    • Stroke at chronic stage.
    • Randomised
  2. Trial II: 2ndclinical evaluation on stroke patients at INNN (Completed)
    • 28 Adults in 3 groups (Control -Occupational Therapy-, Intervention -Gesture Therapy- and Elite -Gesture Therapy and MRI-)
    • Stroke at chronic stage.
    • Randomised
  3. Trial III: 1st multicenter clinical evaluation on cerebral palsy at INP and CRIT-Tlalnepantla (In progress)
    • XX Children in 2 groups (Control -Occupational Therapy-, Intervention -Gesture Therapy-)
    • Cerebral Palsy.
    • Randomised
    • Data collection and analysis finished. Draft in progress.

We now briefly describe these trials and their outcomes:


Clinical Trial I

42 patients were randomised to two groups; a control group of 22 patients received 21 sessions of 60 minutes of occupational therapy, and the intervention group received an equal amount of virtual reality based rehabilitation therapy with Gesture Therapy. Motor improvements were assessed using Fugl-Meyer and Motricity Index scales. Both groups presented a significant improvement in terms of motor recovery (Wilcoxon; p < 0:05). Differences in improvement between the therapies were not significant. A summary of the cohort characteristics and results is presented in Table I. The Intrinsic Motivation Inventory (IMI) is a multidimensional measure of participants’ subjective experience with regard to experimental tasks. It consists of a multi-item questionnaire of which different versions of the questionnaire exist. Motivation as evaluated with the Intrinsic Motivation Inventory (IMI) was stronger among patients treated with Gesture Therapy as suggested in Table II. Patients treated with GT demonstrated greater interest and claimed higher importance and utility. Full details can be found in [SucarLE2010a].

Table I
SUMMARY OF RESULTS OF THE 1ST CLINICAL TRIAL. FM: FUGL-MEYER

Control Intervention
Age (avg.) 51.9 47.9
Gender 12 female, 10 male 14 female, 6 male
Months post-stroke (avg.) 25.7 24.4
Hemiparetic side 3 right, 19 left 4 right, 16 left
FM at start (avg.) 18 19.34
FM at end (avg.) 26.3 31.36

 

TABLE II
MOTIVATION SURVEY MEAN RESULTS FOR THE 1ST CLINICAL TRIAL.

Aspect Control Intervention
Enjoy / Interest 4 15
Perceived Competence 3 12
Effort / Importance 14 20
Pressure / Tension 5 5
Utility / Value 8 19
Pain 2 3

 

Clinical Trial II

28 subjects were allocated to 3 groups; group one received 20 sessions of 45 minutes of occupational therapy, whilst groups 2 and 3 received equal amount of Gesture Therapy, with the third group further undergoing neuroscans for exploration of the neural underpinnings responsible for behavioural improvements. Both therapies exhibited significant motor improvements as evaluated with Fugl-Meyer and Motricity Index (Mann-Whitney U; p < 0:05), and differences in improvements between them were not significant. GT matched the control improvements for hand, wrist and elbow. Prefrontal cortex and cerebellar activity were found to be the driving forces of the recovery associated with Gesture Therapy. We found that those with stronger disabilities appear to benefit the most from this paradigm. A summary of the cohort characteristics and results is presented in Table III. Full details can be found in [OrihuelaEspinaF2011a].

Table III
SUMMARY OF RESULTS OF THE 2ND CLINICAL TRIAL. THE FMRI GROUP RECEIVED VIRTUAL REALITY GT BUT FURTHER UNDERWENT NEUROSCANS
THROUGHOUT THERAPY. FM: FUGL-MEYER

Control Intervention fMRI GT (Intervention + fMRI)
Age (avg.) 46 51.11 38.71 45.68
Gender 4 female, 6 male 7 female, 3 male 4 female, 4 male 11 female, 7 male
Months post-stroke (avg.) 33.76 31.58 44.82 38.20
Hemiparetic side 5 right, 5 left 4 right, 6 left 6 right, 2 left 10 right, 8 left
FM at start (avg.) 33.1 20.44 30.62 25.23
FM at end (avg.) 49.5 30.12 50.37 40.25

 

Clinical Trial III

We are now establishing the validity of the platform for disabilities in children resulting from cerebral palsy. This is a multicenter study (National Institute of Pediatrics, Mexico, and Teleton’s Children Rehabilitation Center (CRIT), Mexico) which will elucidate the clinical benefits of Gesture Therapy in circumstances other than stroke and adult population. Preliminary subjective appreciation is that children enjoy the virtual reality games more than adults, but they require continuous supervision while playing the games so they do perform the exercises correctly. We conjecture that perhaps incorporating a virtual therapist that monitors the child movements and encourages the correct movements and discourages erroneous execution may be beneficial.

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