Sensorimotor Retraining in Chronic Stroke

NCT ID: NCT03058770

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-16
• Study Completion Date: 2018-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sensorimotor retraining program

Fifteen 40-minute sensorimotor retraining sessions will be provided over a 5-week period.

Group Type: EXPERIMENTAL

Sensorimotor retraining

Intervention Type: 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.

Relaxation technique

Subjects will perform fifteen 40-minute relaxation sessions over a 5-week period.

Group Type: ACTIVE_COMPARATOR

Relaxation technique

Intervention Type: OTHER

Subjects will perform guided relaxation by using the Jacobson technique.

Interventions

Sensorimotor retraining

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.

Intervention Type: OTHER

Relaxation technique

Subjects will perform guided relaxation by using the Jacobson technique.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Chronic hemiplegia or hemiparesis from a first ever stroke (onset > 6 months prior to study enrolment)
• No severe cognitive deficit (Mini-Mental State Examination score ≥ 22)
• Subjective reports of sensory loss
• Triceps surae muscles scoring ≤ 2 on the Modified Ashworth Scale
• Able to walk for at least 10 meters indoor over ground without assistance

Exclusion Criteria

• Ataxia
• Co-existing sensory deficits from peripheral neuropathies (i.e. diabetes mellitus)
• Lower extremity claudication
• Pain > 3/10 on a visual analogue scale
• Prior lower extremity surgical history
• Blindness, visual impairments and other pathologic condition that influence posture and balance.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

M. Arantzazu Ruescas Nicolau

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

M. Arántzazu Ruescas-Nicolau, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

M.Luz Sanchez-Sanchez

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

University of Valencia

Valencia, , Spain

Countries

Spain

Other Identifiers

H14831 09435066

Identifier Type: -

Identifier Source: org_study_id