NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy on a Neurophysiological Basis Improves Not Only Pain But Also Mobility in Spastic Paraparesis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Cord
- Sponsor
- Charles University, Czech Republic
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in Muscle strength at 2 weeks, 6 weeks, 6 and 12 months
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
In this project, the aim is to verify that neuromodulation therapy (spinal cord stimulation) in combination with intensive physiotherapy on a neurophysiological basis will lead to the restoration of mobility of lower limbs.
Detailed Description
So far, posterior spinal cord neurostimulation (NM SCS) has been applied as a standard in patients with the most severe forms of pharmacoresistant neuropathic pain. The most recent research of the last 1-2 years brings clinical findings that, in a mode and modified arrangement, it could even induce rhythmic muscle activity of the lower limbs and help in verticalization and assisted bipedal locomotion. In this project, the aim is to verify that neuromodulation therapy SCS (spinal cord stimulation) in combination with intensive physiotherapy on a neurophysiological basis will lead to the restoration of mobility of lower limbs. In the therapy, the neuronal circuits of the lumbosacral region, where the so-called central pattern generators for locomotion are located will be targeted. Neurostimulation of this area will generate motor movement patterns corresponding to the previous mapping of the corresponding muscle groups. These will be supported by intensive physiotherapy on a neurophysiological basis - thanks to it and the facilitation of movement by neurostimulation, global motor patterns will be triggered, and motor programs stored at the subcortical level will be activated. Their memorization and subsequent spontaneous retrieval will facilitate sensorimotor learning techniques. Current research further shows that neurostimulation stimulates neurons in Rexed laminae 3-5, specifically a group of neurons designated as SC VSX2 and subsequently proprioceptive fibres. Physiotherapy will enhance the effect of neuromodulation by stimulating proprioceptors using soft and neurophysiologically based techniques. Proprioceptive fibres make connections to motoneurons and also ascend through the spinal cord to the brain, and thus reflex motor movements can be triggered. Information about them is carried to the brain by ascending pathways, and thus a free awareness of the movement facilitated by the neurostimulator occurs. All these mechanisms should potentiate plasticity (and lead to the restoration of locomotion.
Investigators
Kamila Řasová
assoc. prof. PhDr. Kamila Řasová, Ph.D.
Charles University, Czech Republic
Eligibility Criteria
Inclusion Criteria
- •spinal cord lesion
Exclusion Criteria
- •other neurological conditions
Outcomes
Primary Outcomes
Change in Muscle strength at 2 weeks, 6 weeks, 6 and 12 months
Time Frame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
Hip flexion, abduction and extension, knee flexion and extension, plantar flexion and dorsiflexion using a microFET2 digital dynamometer. The higher value, the better function (higher strength).
Change in Spasticity at 2 weeks, 6 weeks, 6 and 12 months
Time Frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
Hip flexors, knee flexors and extensors, dorsal and plantar flexors using the Modified Ashworth scale. The higher value, the worse function (higher spasticity).
Change from Baseline Timed Up And Go at 2 weeks, 6 weeks, 6 and 12 months
Time Frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
The subject stands up from a chair, walks 3m, turns back, and sits down again as quickly and safely as possible while being timed. Higher times reflect worse mobility.
Change from Baseline Berg Balance Scale at 2 weeks, 6 weeks, 6 and 12 months
Time Frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
The subject stands up from a chair, walks 3m, turns back, and sits down again as quickly and safely as possible while being timed. Higher times reflect worse mobility.
Change from Baseline The 6 Minute Walk Test at 2 weeks, 6 weeks, 6 and 12 months
Time Frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
A long walking capacity test recording the maximal distance a subject walks at the fastest speed possible in 6 minutes. The more distance covered, the better the walking performance is.
Change from Baseline The 10 Metre Walk Test at 2 weeks, 6 weeks, 6 and 12 months
Time Frame: Post-assessment 1 (immediately after the end of two weeks hospitalisation)
A performance measure used to assess walking speed in meters per second over 10 meters. Shorter times reflect better mobility.
Change in Walking Index for Spinal Cord Injury at 2 weeks, 6 weeks, 6 and 12 months
Time Frame: Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).
questionnaire from 0 to 20. Higher number means better function.
Secondary Outcomes
- Change in SYMBOL DIGIT MODALITIES TEST at 2 weeks, 6 weeks, 6 and 12 months(Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).)
- Change in Visual Analogue Scale for pain at 2 weeks, 6 weeks, 6 and 12 months(Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).)
- Change in European Health Questionnaire at 2 weeks, 6 weeks, 6 and 12 months(Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).)
- Change in the 36-Item Short Form Survey Instrument at 2 weeks, 6 weeks, 6 and 12 months(Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).)
- Change in the Spinal Cord Independence Measure at 2 weeks, 6 weeks, 6 and 12 months(Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).)
- Change in The Fatigue Scale for Motor and Cognitive Functions at 2 weeks, 6 weeks, 6 and 12 months(Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).)
- Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 2 weeks, 6 weeks, 6 and 12 months(Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).)
- Change from Baseline Goal Attainment scale at 2 weeks, 6 weeks, 6 and 12 months(Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study).)