StrokeNCT03058770
Sensorimotor Retraining in Chronic Stroke
A study testing Sensorimotor retraining and Relaxation technique in people with Stroke, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Sensorimotor retraining and Relaxation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of a Sensorimotor Retraining Program in Chronic Stroke
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.
Read the 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
- Being tested
- Sensorimotor retraining, Relaxation technique
- Keywords
- chronic stroke, sensorimotor retraining
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor retrainingOther
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 techniqueOther
Subjects will perform guided relaxation by using the Jacobson technique.
| Study group | Role | What they receive |
|---|---|---|
| sensorimotor retraining program | Experimental | Fifteen 40-minute sensorimotor retraining sessions will be provided over a 5-week period. Receives: Other: Sensorimotor retraining |
| Relaxation technique | Active comparator | Subjects will perform fifteen 40-minute relaxation sessions over a 5-week period. Receives: Other: Relaxation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light touch
Von Frey monofilaments
Measured: 6 weeks
Secondary outcomes (3)
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
Measured: 6 weeks
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.
Measured: 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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start16 Feb 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Arantzazu Ruescas Nicolau, University of Valencia
- Investigators
- M. Arántzazu Ruescas-Nicolau, PhD, Principal investigator, University of ValenciaM.Luz Sanchez-Sanchez, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058770
- Sponsor's protocol ID
- H14831 09435066
- Status last verified
- May 2024
- First submitted
- 16 Feb 2017
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of a Sensorimotor Retraining Program in Chronic Stroke
- ClinicalTrials.gov ID
- NCT03058770
- Acronym / sponsor ID
- H14831 09435066
- Conditions
- Stroke
- Keywords
- chronic stroke, sensorimotor retraining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sensorimotor retraining program | Experimental | Other: Sensorimotor retrainingFifteen 40-minute sensorimotor retraining sessions will be provided over a 5-week period. |
| Relaxation technique | Active comparator | Other: Relaxation techniqueSubjects will perform fifteen 40-minute relaxation sessions over a 5-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensorimotor retrainingSubjects 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. | Other | sensorimotor retraining program |
| Relaxation techniqueSubjects will perform guided relaxation by using the Jacobson technique. | Other | Relaxation technique |
Primary outcome
Light touch
Time frame: 6 weeks
Von Frey monofilaments
3 secondary outcomes
Static balance
Time frame: 6 weeks
Plantar pressure distribution
Time frame: 6 weeks
Gait
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Arántzazu Ruescas-Nicolau, PhD principal investigator
University of Valencia
M.Luz Sanchez-Sanchez principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorimotor retraining and Relaxation technique in people with Stroke, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Light touch (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.