Sensorimotor Retraining in Chronic Stroke
Study of the Effect of a Sensorimotor Retraining Program in Chronic Stroke
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2017
CompletedStudy Start
First participant enrolled
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedMay 16, 2024
May 1, 2024
1.1 years
February 16, 2017
May 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Light touch
Von Frey monofilaments
6 weeks
Secondary Outcomes (3)
Static balance
6 weeks
Plantar pressure distribution
6 weeks
Gait
6 week
Study Arms (2)
sensorimotor retraining program
EXPERIMENTALFifteen 40-minute sensorimotor retraining sessions will be provided over a 5-week period.
Relaxation technique
ACTIVE COMPARATORSubjects will perform fifteen 40-minute relaxation sessions over a 5-week period.
Interventions
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.
Subjects will perform guided relaxation by using the Jacobson technique.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Valencia
Valencia, 46010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M. Arántzazu Ruescas-Nicolau, PhD
University of Valencia
- PRINCIPAL INVESTIGATOR
M.Luz Sanchez-Sanchez
University of Valencia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
February 16, 2017
First Posted
February 23, 2017
Study Start
February 16, 2017
Primary Completion
March 31, 2018
Study Completion
March 31, 2018
Last Updated
May 16, 2024
Record last verified: 2024-05