StrokeSENSUPPNCT03336749
Sensory Re-learning of the Upper Limb After Stroke
A study testing Sensory group in people with Stroke, run by Lund University at 1 site in Sweden.
Trial summary
The overall aim of this study is to investigate if sensory re-learning in combination with task-specific training is more effective than task-specific training alone to improve sensory function of the hand, dexterity, the ability to use the hand in daily activities, perceived participation and life satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Sensory group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2017to 4 Feb 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sensory impairments (≤5 points in Shape-Texture Identification test) of upper limb after stroke
- ability to grasp and release an object
- be able to understand oral and written information
- 18-80 years of age
- at least 6 months since stroke onset
- be able to walk with or without an assistive device
Who cannot join
- sensory impairments of the UL due to other diagnosis than stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SENSory Re-learning of the UPPer Limb After Stroke (SENSUPP): a Pilot Randomized Controlled Trial
The overall aim of this study is to investigate if sensory re-learning in combination with task-specific training is more effective than task-specific training alone to improve sensory function of the hand, dexterity, the ability to use the hand in daily activities, perceived participation and life satisfaction.
Read the detailed description
More than half of stroke survivors suffer from sensory impairments of their affected upper limb (UL), which can lead to long term problems to use the UL in daily life, such as personal care, household- and leisure activities. Few studies have evaluated if sensory re-learning in combination with task-specific training can improve the ability to perform daily hand activities and perceived participation. Therefore, there is a need for more studies. This is a single-blinded pilot randomized controlled trial with two treatment arms. Thirty persons with sensory impairments of the UL after stroke will be recruited and randomized to either sensory re-learning in combination with task-specific training or to task-specific training only. The training will consist of 2.5 hours of group training per session, 2 times per week for 5 weeks. Assessments will be conducted pre- and post-training and at 3 months' after the intervention.
Descriptive statistics (mean (SD) or median (min- max) will be used to characterize the study groups. Non-parametric statistics will be used for ordinal data and parametric statistics for continues data. To analyze between group differences, the Mann-Whitney test or Independent sample t-test will be used and Wilcoxon signed ranks test or paired t-test to analyze within group differences. The level of statistical significance will be set at p < 0.05.
- Conditions
- Stroke
- Being tested
- Sensory group, Control group
- Keywords
- Stroke, upper limb, sensory training, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory groupBehavioural
The sensory re-learning consists of touch detection practice, i.e., touch discrimination to identify different materials, shapes, textures, weights and temperatures, proprioception and tactile object recognition in combination with task-specific training.
Control groupOther
Traditional task-specific training
| Study group | Role | What they receive |
|---|---|---|
| Sensory group | Experimental | Sensory re-learning in combination with task-specific training Receives: Behavioral: Sensory group |
| Control group | Active comparator | Traditional task-specific training Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Semmes- Weinstein monofilament (SWM) test from baseline to post intervention and from baseline to 3 month follow-up.
Assess touch detection thresholds of the hand and fingers. The short version with 5 filaments from 0.07 gram to 279 grams will be used. The touch detection thresholds are scored on a 0 to 5-point scale, where 5 represents the thinnest filament and 0 represents the largest filament. Five different positions of the hand are tested: fingertip on digit I, II, V and on the thenar and hypothenar region. Both hands are tested and the total sum score is 25 for each hand.
Measured: Baseline, 5 weeks, 3 months.
Change in Shape- Texture Identification test (STI) from baseline to post intervention and from baseline to 3 month follow-up.
Measures the ability to identify shapes and textures. Both the affected and non- affected hand are tested and the scores range from 0 to 3 points per hand for each subtest with a maximum score of 6 points.
Measured: Baseline, 5 weeks, 3 months.
Change in Fugl- Meyer Assessment (FMA-UE) sensory section from baseline to post intervention and from baseline to 3 month follow-up.
Measures light touch and proprioception of the upper limb after stroke. The score ranges from 0 to 4 points for each subtest with a maximum score of 8 points per hand.
Measured: Baseline, 5 weeks, 3 months.
Change in Tactile object identification test from baseline to post intervention and from baseline to 3 month follow-up.
Measures the ability to identify different objects without vision. Out of 20 objects, 15 are used during the assessment. Within 15 seconds the participant should blind-fold recognize an object. Correct answer yields 2 points, recognition of some feature of the object yields 1 point and incorrect answer 0 points; thus a maximum total sum score of 30 points.
Measured: Baseline, 5 weeks, 3 months.
Secondary outcomes (8)
Change in Box and Block Test (BBT) from baseline to post intervention and from baseline to 3 month follow-up.
Measures gross manual dexterity. It consists of a box with two compartments and of 100 wooden blocks. The number of blocks that can be transported from one compartment to the other during 1 minute is counted.
Measured: Baseline, 5 weeks, 3 month.
Change in Mini Sollerman Hand Function Test (mSHFT) from baseline to post intervention and from baseline to 3 month follow-up.
Measures fine motor dexterity. It consists of three tasks: (1) picking up four coins from a purse, (2) putting four nuts on bolts and (3) buttoning four buttons in decreasing sizes. The score ranges from 0 to 4 points for each task with a maximum score of 12 points.
Measured: Baseline, 5 weeks, 3 month.
Change in Modified Motor Assessment Scale (M-MAS) for the upper limb from baseline to post intervention and from baseline to 3 month follow-up..
Measures fine motor dexterity. The scale ranges from 0 to 5 points where 0 point represents no motor function and 5 points represents almost normal or normal motor function.
Measured: Baseline, 5 weeks, 3 month.
Change in Grippit from baseline to post intervention and from baseline to 3 month follow-up.
Grip strength, the highest isometric contraction of three trials is recorded in Newton (N).
Measured: Baseline, 5 weeks, 3 month.
Changes in Motor Activity Log (MAL) from baseline to post intervention and from baseline to 3 month follow-up.
Measures activity in daily living with a 30-item scale where the participants rate how much (amount of use; AOU) and how well (quality of movement; QOM) they use their affected hand in daily activities. The score ranges from 0 (never use the affected arm for this activity) to 5 (always use the affected arm for this activity) and for QOM from 0 (inability to use the affected arm for this activity) to 5 (ability to use the affected arm for this activity just as well as before the stroke).
Measured: Baseline, 5 weeks, 3 month.
Change in Canadian Occupational Performance Measure (COPM) from baseline to post intervention and from baseline to 3 month follow-up.
Perceived difficulties in daily activities. This is a client-centered interview based outcome measure, where the participants identify problems in their execution of activities in self-care, productivity and leisure activities. The self-perceived performance and satisfaction of their sensory related problems are rated on a scale ranging from 1 (not able to do respective not satisfied) to 10 (able to do extremely well respective extremely satisfied). Higher ratings indicate better performance and more satisfaction.
Measured: Baseline, 5 weeks, 3 month.
change in Stroke Impact Scale, (SIS) Participation domain from baseline to post intervention and from baseline to 3 month follow-up.
It measures a person's perceived participation through eight items, i.e., how stroke impact on work, social activities, quiet recreations, active recreations, role as a family member, religious activities, life control and ability to help others. Every item is scored on a 5- grade scale from 5 (none of the time) to 1 (all of the time).
Measured: Baseline, 5 weeks, 3 month.
Change in Life Satisfaction Scale (LiSat) from baseline to post intervention and from baseline to 3 month follow-up.
Measures life satisfaction. In this study the item 'My life as a whole' will be used, ratings ranges from 1= very dissatisfied to 6= very satisfied.
Measured: Baseline, 5 weeks, 3 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Apr 2017
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Brogardh, Lund University
- Investigators
- Christina Brogårdh, Principal investigator, Department of Health Sciences, Faculty of Medicine, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336749
- Sponsor's protocol ID
- Sensory
- Acronym
- SENSUPP
- Status last verified
- Feb 2021
- First submitted
- 31 Oct 2017
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Carlsson H, Rosen B, Bjorkman A, Pessah-Rasmussen H, Brogardh C. SENSory re-learning of the UPPer limb (SENSUPP) after stroke: development and description of a novel intervention using the TIDieR checklist. Trials. 2021 Jul 5;22(1):430. doi: 10.1186/s13063-021-05375-6.
PubMed 34225764Carlsson H, Rosen B, Pessah-Rasmussen H, Bjorkman A, Brogardh C. SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial. Trials. 2018 Apr 17;19(1):229. doi: 10.1186/s13063-018-2628-1.
PubMed 29665842
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENSory Re-learning of the UPPer Limb After Stroke (SENSUPP): a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03336749
- Acronym / sponsor ID
- SENSUPP / Sensory
- Conditions
- Stroke
- Keywords
- Stroke, upper limb, sensory training, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 8 Nov 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.
The overall aim of this study is to investigate if sensory re-learning in combination with task-specific training is more effective than task-specific training alone to improve sensory function of the hand, dexterity, the ability to use the hand in daily activities, perceived participation and life satisfaction.
Detailed description
More than half of stroke survivors suffer from sensory impairments of their affected upper limb (UL), which can lead to long term problems to use the UL in daily life, such as personal care, household- and leisure activities. Few studies have evaluated if sensory re-learning in combination with task-specific training can improve the ability to perform daily hand activities and perceived participation. Therefore, there is a need for more studies. This is a single-blinded pilot randomized controlled trial with two treatment arms. Thirty persons with sensory impairments of the UL after stroke will be recruited and randomized to either sensory re-learning in combination with task-specific training or to task-specific training only. The training will consist of 2.5 hours of group training per session, 2 times per week for 5 weeks. Assessments will be conducted pre- and post-training and at 3 months' after the intervention.
Descriptive statistics (mean (SD) or median (min- max) will be used to characterize the study groups. Non-parametric statistics will be used for ordinal data and parametric statistics for continues data. To analyze between group differences, the Mann-Whitney test or Independent sample t-test will be used and Wilcoxon signed ranks test or paired t-test to analyze within group differences. The level of statistical significance will be set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Sensory group | Experimental | Behavioral: Sensory groupSensory re-learning in combination with task-specific training |
| Control group | Active comparator | Other: Control groupTraditional task-specific training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- sensory impairments (≤5 points in Shape-Texture Identification test) of upper limb after stroke
- ability to grasp and release an object
- be able to understand oral and written information
- 18-80 years of age
- at least 6 months since stroke onset
Key exclusion criteria (1 listed)
- sensory impairments of the UL due to other diagnosis than stroke
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 groupThe sensory re-learning consists of touch detection practice, i.e., touch discrimination to identify different materials, shapes, textures, weights and temperatures, proprioception and tactile object recognition in combination with task-specific training. | Behavioural | Sensory group |
| Control groupTraditional task-specific training | Other | Control group |
Primary outcome
Change in Semmes- Weinstein monofilament (SWM) test from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 months.
Assess touch detection thresholds of the hand and fingers. The short version with 5 filaments from 0.07 gram to 279 grams will be used. The touch detection thresholds are scored on a 0 to 5-point scale, where 5 represents the thinnest filament and 0 represents the largest filament. Five different positions of the hand are tested: fingertip on digit I, II, V and on the thenar and hypothenar region. Both hands are tested and the total sum score is 25 for each hand.
Change in Shape- Texture Identification test (STI) from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 months.
Measures the ability to identify shapes and textures. Both the affected and non- affected hand are tested and the scores range from 0 to 3 points per hand for each subtest with a maximum score of 6 points.
Change in Fugl- Meyer Assessment (FMA-UE) sensory section from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 months.
Measures light touch and proprioception of the upper limb after stroke. The score ranges from 0 to 4 points for each subtest with a maximum score of 8 points per hand.
Change in Tactile object identification test from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 months.
Measures the ability to identify different objects without vision. Out of 20 objects, 15 are used during the assessment. Within 15 seconds the participant should blind-fold recognize an object. Correct answer yields 2 points, recognition of some feature of the object yields 1 point and incorrect answer 0 points; thus a maximum total sum score of 30 points.
8 secondary outcomes
Change in Box and Block Test (BBT) from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 month.
Change in Mini Sollerman Hand Function Test (mSHFT) from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 month.
Change in Modified Motor Assessment Scale (M-MAS) for the upper limb from baseline to post intervention and from baseline to 3 month follow-up..
Time frame: Baseline, 5 weeks, 3 month.
Change in Grippit from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 month.
Changes in Motor Activity Log (MAL) from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 month.
Change in Canadian Occupational Performance Measure (COPM) from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 month.
change in Stroke Impact Scale, (SIS) Participation domain from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 month.
Change in Life Satisfaction Scale (LiSat) from baseline to post intervention and from baseline to 3 month follow-up.
Time frame: Baseline, 5 weeks, 3 month.
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 21 Feb 2021.
- Derived from this study: PubMed 34225764Carlsson H, Rosen B, Bjorkman A, Pessah-Rasmussen H, Brogardh C. SENSory re-learning of the UPPer limb (SENSUPP) after stroke: development and description of a novel intervention using the TIDieR checklist. Trials. 2021 Jul 5;22(1):430. doi: 10.1186/s13063-021-05375-6.
- Derived from this study: PubMed 29665842Carlsson H, Rosen B, Pessah-Rasmussen H, Bjorkman A, Brogardh C. SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial. Trials. 2018 Apr 17;19(1):229. doi: 10.1186/s13063-018-2628-1.
- Individual participant dataSharing planned: Undecided
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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.
Christina Brogårdh principal investigator
Department of Health Sciences, Faculty of Medicine, Lund University
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 group in people with Stroke, run by Lund University at 1 site in Sweden.
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 6 inclusion and 1 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 21 Feb 2021. 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 Sweden. 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 Semmes- Weinstein monofilament (SWM) test from baseline to post intervention and from baseline to 3 month follow-up. (time frame: Baseline, 5 weeks, 3 months.). The study lists 4 primary outcomes in all. 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 NCT03336749, which also lists 2 linked publications.
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 21 Feb 2021.