Clinical trial NCT03336749: Sensory Re-learning of the Upper Limb After Stroke
Official title: SENSory Re-learning of the UPPer Limb After Stroke (SENSUPP): a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke, upper limb, sensory training, rehabilitation
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

• sensory impairments of the UL due to other diagnosis than stroke

Primary outcomes:
measure: Change in Semmes- Weinstein monofilament (SWM) test from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 months.
measure: Change in Shape- Texture Identification test (STI) from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 months.
measure: Change in Fugl- Meyer Assessment (FMA-UE) sensory section from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 months.
measure: Change in Tactile object identification test from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 months.
Secondary outcomes:
measure: Change in Box and Block Test (BBT) from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 month.
measure: Change in Mini Sollerman Hand Function Test (mSHFT) from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 month.
measure: 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..
timeFrame: Baseline, 5 weeks, 3 month.
measure: Change in Grippit from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 month.
measure: Changes in Motor Activity Log (MAL) from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 month.
measure: Change in Canadian Occupational Performance Measure (COPM) from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 month.
measure: change in Stroke Impact Scale, (SIS) Participation domain from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 month.
measure: Change in Life Satisfaction Scale (LiSat) from baseline to post intervention and from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks, 3 month.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Department of Health Sciences, Faculty of Medicine, Lund University
name: Christina Brogårdh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Carlsson 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.