StrokeNCT01988220
The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment
A study testing sensory retraining and repeated sensory input in people with Stroke and Sensory Deficits, run by Yocheved Laufer at 1 site in Israel.
Trial summary
Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory deficits. Sensory impairments are often overlooked in the therapeutic setting, although they lead to slower motor recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Sensory Deficits
- What is being tested?
- sensory retraining and repeated sensory input
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Dec 2017
- 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
- post stroke
- at least 6 months after stroke
- with sensory deficits in study's screening tests
Who cannot join
- other neurologic condition
- peripheral neuropathy
- pacemaker
- hemispatial neglect
Trial locations and contacts
1 site in 1 country.
About this study
Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory deficits. Sensory impairments are often overlooked in the therapeutic setting, although they lead to slower motor recovery.
Working hypothesis: The overall goal of this study is to examine the effectiveness of a sensory discrimination reeducation oriented therapeutic program to the lower limb of stroke patients with sensory impairments. We assume that subjects to both groups will make progress, which will be more significant in the experimental group.
Read more
Methods: Study population and design: Sixty individuals with chronic sensory impairment following a stroke will be recruited. Patients will be randomly assigned to sensory retraining treatment or to sensory stimulation treatment. Treatment will consist of ten 45 minute long intervention sessions, carried out within a 6 weeks period, and a home exercise program. The person conducting the assessments will be blind to the treatment allocation of the subjects. Outcome measures: The efficacy of the intervention will be determined in relation to the International Classification of Functionality (ICF) developed by the World Health Organization and will include assessments at the three domains defined by this model: 1. Body structure and function - determined by measures of the sensory capacity of the lower more affected limb; 2. Activities - determined by measures of balance and gait; 3. Participation - determined by measures of well-being and social reintegration.
Two new outcome measures, for ankle and knee position sense and for texture discrimination of the foot, will be developed within this study. Data reliability measures on healthy population, and test - retest measures in post stroke population with be collected.
Intervention: The experimental group will be treated by a perception learning oriented protocol for sensory reeducation, to improve identification, localization and discrimination of sensory stimuli, including electrical stimulation, texture and hardness discrimination and position sense training. The control group will receive the same stimuli without the attentive learning and discriminating component.
Importance: Scientific proof and focused recommendations for a potent therapeutic method for the post-stroke population, allowing them better participation and quality of life.
Key words: Stroke, sensory impairment, perceptual learning, lower limb, clinical trial.
- Conditions
- Stroke, Sensory Deficits
- Being tested
- sensory retraining, repeated sensory input
- Keywords
- stroke, sensory deficit, sensory retraining, perceptual learning, lower extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory retrainingOther
Also called perceptual learning, sensory reeducation
repeated sensory inputOther
sensory stimulation without attentive learning focus
| Study group | Role | What they receive |
|---|---|---|
| sensory retraining | Experimental | sensory identification and discrimination training. using different attention and sensation modalities for sensory retraining Receives: Other: sensory retraining |
| repeated exposure to sensory input | Active comparator | Not described Receives: Other: repeated sensory input |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Timed Up and Go test
Standing up from a chair, walking three meters, turning around and coming back to sitting. time is assessed.
Measured: pre - up to a week before intervention, post - after 6 weeks, follow-up - 3 months after
Secondary outcomes (1)
Von Frey monofilaments foot identification threshold
Assessment of threshold for Von Frey monofilaments identification, using the levels method. Starting with monofilament 5.07, two points will be assessed - dorsal mid foot and anterior mid ankle.
Measured: screening - one week before pretest, pre - up to one week before intervention, post - 6 weeks after, follow-up - 3 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startDec 2014
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yocheved Laufer
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services, Haifa and West Galilee
- Responsible party
- Sponsor-investigator, Yocheved Laufer, University of Haifa
- Investigators
- Mordechai Alperin, MD, Principal investigator, Clalit Health ServicesHadas Ofek, PhD student, Study director, University of HaifaYocheved Laufer, Professor, Study chair, University of HaifaUzi Milman, MD, Study chair, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988220
- Sponsor's protocol ID
- UHai012013
- Status last verified
- May 2018
- First submitted
- 5 Nov 2013
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ofek H, Alperin M, Knoll T, Livne D, Laufer Y. Explicit versus implicit lower extremity sensory retraining for post-stroke chronic sensory deficits: a randomized controlled trial. Disabil Rehabil. 2023 Jun;45(12):1962-1968. doi: 10.1080/09638288.2022.2080288. Epub 2022 Jun 1.
PubMed 35649684
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lower Extremity Sensory Retraining Treatment in Individuals With Post-stroke Sensory Impairment
- ClinicalTrials.gov ID
- NCT01988220
- Acronym / sponsor ID
- UHai012013
- Conditions
- Stroke, Sensory Deficits
- Keywords
- stroke, sensory deficit, sensory retraining, perceptual learning, lower extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yocheved LauferUniversity, hospital or other
- Collaborators
- Clalit Health Services, Haifa and West Galilee
- Study start
- Dec 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Nov 2013 (estimated)
- 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.
Background: It is estimated that 50%-85% of individuals post stroke demonstrate sensory deficits. Sensory impairments are often overlooked in the therapeutic setting, although they lead to slower motor recovery.
Working hypothesis: The overall goal of this study is to examine the effectiveness of a sensory discrimination reeducation oriented therapeutic program to the lower limb of stroke patients with sensory impairments. We assume that subjects to both groups will make progress, which will be more significant in the experimental group.
Methods: Study population and design: Sixty individuals with chronic sensory impairment following a stroke will be recruited. Patients will be randomly assigned to sensory retraining treatment or to sensory stimulation treatment. Treatment will consist of ten 45 minute long intervention sessions, carried out within a 6 weeks period, and a home exercise program. The person conducting the assessments will be blind to the treatment allocation of the subjects. Outcome measures: The efficacy of the intervention will be determined in relation to the International Classification of Functionality (ICF) developed by the World Health Organization and will include assessments at the three domains defined by this model: 1. Body structure and function - determined by measures of the sensory capacity of the lower more affected limb; 2. Activities - determined by measures of balance and gait; 3. Participation - determined by measures of well-being and social reintegration.
Two new outcome measures, for ankle and knee position sense and for texture discrimination of the foot, will be developed within this study. Data reliability measures on healthy population, and test - retest measures in post stroke population with be collected.
Intervention: The experimental group will be treated by a perception learning oriented protocol for sensory reeducation, to improve identification, localization and discrimination of sensory stimuli, including electrical stimulation, texture and hardness discrimination and position sense training. The control group will receive the same stimuli without the attentive learning and discriminating component.
Importance: Scientific proof and focused recommendations for a potent therapeutic method for the post-stroke population, allowing them better participation and quality of life.
Key words: Stroke, sensory impairment, perceptual learning, lower limb, clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sensory retraining | Experimental | Other: sensory retrainingsensory identification and discrimination training. using different attention and sensation modalities for sensory retraining |
| repeated exposure to sensory input | Active comparator | Other: repeated sensory input |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- post stroke
- at least 6 months after stroke
- with sensory deficits in study's screening tests
Key exclusion criteria (4 listed)
- other neurologic condition
- peripheral neuropathy
- pacemaker
- hemispatial neglect
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 |
|---|---|---|
| sensory retrainingAlso: perceptual learning, sensory reeducation | Other | sensory retraining |
| repeated sensory inputsensory stimulation without attentive learning focus | Other | repeated exposure to sensory input |
Primary outcome
Change in Timed Up and Go test
Time frame: pre - up to a week before intervention, post - after 6 weeks, follow-up - 3 months after
Standing up from a chair, walking three meters, turning around and coming back to sitting. time is assessed.
1 secondary outcome
Von Frey monofilaments foot identification threshold
Time frame: screening - one week before pretest, pre - up to one week before intervention, post - 6 weeks after, follow-up - 3 months after
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 3 May 2018.
- Derived from this study: PubMed 35649684Ofek H, Alperin M, Knoll T, Livne D, Laufer Y. Explicit versus implicit lower extremity sensory retraining for post-stroke chronic sensory deficits: a randomized controlled trial. Disabil Rehabil. 2023 Jun;45(12):1962-1968. doi: 10.1080/09638288.2022.2080288. Epub 2022 Jun 1.
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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.
Mordechai Alperin, MD principal investigator
Clalit Health Services
Hadas Ofek, PhD student study director
University of Haifa
Yocheved Laufer, Professor study chair
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory retraining and repeated sensory input in people with Stroke and Sensory Deficits, run by Yocheved Laufer at 1 site in Israel.
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 3 inclusion and 4 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 3 May 2018. 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 Israel. 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?
Change in Timed Up and Go test (time frame: pre - up to a week before intervention, post - after 6 weeks, follow-up - 3 months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988220, which also lists 1 linked publication.
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 3 May 2018.