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A prospective, randomized double-blind clinical trial will be conducted to determine the effect of a sensorimotor retraining program on the sensory and functional recovery of the paretic lower limb of subjects with chronic sequelae from stroke.
Somatosensory deficits are a common symptom after stroke, affecting a high percentage of survivors (50-80%). These impairments have a long-term influence on somatosensory capacity, motor ability and functional performance. Although several authors have studied the effect of sensorimotor retraining on recovery of the paretic upper limb, a few have investigated its effect on the paretic lower limb. Furthermore, most of them have done so in the acute and subacute phases after stroke. Thus, in this field there is a lack of studies of high methodological quality that provide effective physiotherapeutic interventions, especially in chronic stroke.
On the other hand, the importance of motor recovery of the paretic lower limb in order to achieve a better balance, gait and independence in the activities of daily living is well established. In this regard, sensory loss in the feet may difficult effective motor function recovery due to its impacts upon ambulatory activity. After stroke, sensory dysfunction in the lower limb has been related to reductions in static and dynamic balance as well as in gait speed and symmetry. Therefore, successful recovery of sensory function after stroke may allow for the appropriate integration of sensory inputs in order to maintain balance and adapt to changing environmental demands during gait.
Since the current evidence indicates that there may be recovery of sensory loss during the chronic phase of stroke, the present study aims to evaluate the effect of a sensorimotor retraining program on sensory and functional recovery of the paretic lower limb in chronic stroke. The investigators hypothesized that stroke survivors receiving the somatosensory training program would demonstrate significantly greater improvement in sensation, static and dynamic balance and gait pattern in comparison with the control intervention.
To cope with the objective of the study, a prospective randomized double-blind clinical trial will be conducted. By means of advertisements in supporting groups, rehabilitation facilities and the external consultations of various hospitals, subjects who meet the inclusion criteria will be recruited. After screening and giving signed consent, participants will be randomly allocated to the intervention group or the control group. In addition to the usual physical activity, participants will complete fifteen 40-minute sessions of sensorimotor retraining (intervention group) or of Jacobson relaxation (control group) over a 5-week period. Participants will be assessed prior to treatment and on completion of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sensorimotor retraining program | Experimental | Fifteen 40-minute sensorimotor retraining sessions will be provided over a 5-week period. |
|
| Relaxation technique | Active Comparator | Subjects will perform fifteen 40-minute relaxation sessions over a 5-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensorimotor retraining | Other | Subjects will receive education regarding sensation and sensory retraining; practice in detection and localization of touch and in discrimination of hardness, texture and temperature in sitting and standing with vision obscured; proprioception training; and practice of these sensations in functional activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Light touch | Von Frey monofilaments | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Static balance | Stabilometric parameters (Romberg test (eyes open and close) and the limits of stability test in 8 directions) registered on the NedSVE/IBVv4 force plate system | 6 weeks |
| Plantar pressure distribution |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Arántzazu Ruescas-Nicolau, PhD | University of Valencia | Principal Investigator |
| M.Luz Sanchez-Sanchez | University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Valencia | Valencia | 46010 | Spain |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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|
| Relaxation technique | Other | Subjects will perform guided relaxation by using the Jacobson technique. |
|
Percentage of weight supported under each foot during upright position and the symmetry ratio between feet assesed by using computerized baropodometric analysis.
| 6 weeks |
| Gait | Biomechanical analysis of the ground reaction forces, gait speed and single leg supporting time registered on the NedSVE/IBVv4 force plate system. | 6 week |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |