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Sensorimotor Retraining in Chronic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sensorimotor retraining
Relaxation technique
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring chronic stroke, sensorimotor retraining

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sensorimotor retraining program

Relaxation technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

Light touch
Von Frey monofilaments

Secondary Outcome Measures

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
Plantar pressure distribution
Percentage of weight supported under each foot during upright position and the symmetry ratio between feet assesed by using computerized baropodometric analysis.
Gait
Biomechanical analysis of the ground reaction forces, gait speed and single leg supporting time registered on the NedSVE/IBVv4 force plate system.
Dynamic balance
Postural stability during various walking tasks assessed by the Functional Gait Assessment Test

Full Information

First Posted
February 16, 2017
Last Updated
December 26, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT03058770
Brief Title
Sensorimotor Retraining in Chronic Stroke
Official Title
Study of the Effect of a Sensorimotor Retraining Program in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
chronic stroke, sensorimotor retraining

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sensorimotor retraining program
Arm Type
Experimental
Arm Description
Fifteen 40-minute sensorimotor retraining sessions will be provided over a 5-week period.
Arm Title
Relaxation technique
Arm Type
Active Comparator
Arm Description
Subjects will perform fifteen 40-minute relaxation sessions over a 5-week period.
Intervention Type
Other
Intervention Name(s)
Sensorimotor retraining
Intervention Description
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
Intervention Name(s)
Relaxation technique
Intervention Description
Subjects will perform guided relaxation by using the Jacobson technique.
Primary Outcome Measure Information:
Title
Light touch
Description
Von Frey monofilaments
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Static balance
Description
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
Time Frame
6 weeks
Title
Plantar pressure distribution
Description
Percentage of weight supported under each foot during upright position and the symmetry ratio between feet assesed by using computerized baropodometric analysis.
Time Frame
6 weeks
Title
Gait
Description
Biomechanical analysis of the ground reaction forces, gait speed and single leg supporting time registered on the NedSVE/IBVv4 force plate system.
Time Frame
6 week
Title
Dynamic balance
Description
Postural stability during various walking tasks assessed by the Functional Gait Assessment Test
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Arántzazu Ruescas-Nicolau, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M.Luz Sanchez-Sanchez
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

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Sensorimotor Retraining in Chronic Stroke

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