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Sensory Re-learning of the Upper Limb After Stroke (SENSUPP)

This study is currently recruiting participants.
Verified November 2017 by Christina Brogardh, Lund University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03336749
First Posted: November 8, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Christina Brogardh, Lund University
October 31, 2017
November 8, 2017
November 8, 2017
April 1, 2017
December 31, 2019   (Final data collection date for 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. ]
    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.
Same as current
No Changes Posted
  • 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. ]
    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.
  • 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. ]
    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.
  • 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. ]
    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.
  • Change in Grippit from baseline to post intervention and from baseline to 3 month follow-up. [ Time Frame: Baseline, 5 weeks, 3 month. ]
    Grip strength, the highest isometric contraction of three trials is recorded in Newton (N).
  • 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. ]
    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).
  • 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. ]
    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.
  • 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. ]
    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).
  • 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. ]
    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.
Same as current
Not Provided
Not Provided
 
Sensory Re-learning of the Upper Limb After Stroke
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are assigned to one of two or more groups in parallel for the duration of the study
Masking: Single (Outcomes Assessor)
Masking Description:
The assessors are blinded to the participants' group allocation.
Primary Purpose: Treatment
Stroke
  • Behavioral: Sensory group
    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.
  • Other: Control group
    Traditional task-specific training
  • Experimental: Sensory group
    Sensory re-learning in combination with task-specific training
    Intervention: Behavioral: Sensory group
  • Active Comparator: Control group
    Traditional task-specific training
    Intervention: Other: Control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 31, 2019
December 31, 2019   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Håkan Carlsson +4673 0753217 Hakan.Carlsson@med.lu.se
Contact: Christina Brogårdh +4676 6486320 Christina.Brogardh@med.lu.se
Sweden
 
 
NCT03336749
Sensory
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Christina Brogardh, Lund University
Lund University
Not Provided
Principal Investigator: Christina Brogårdh Department of Health Sciences, Faculty of Medicine, Lund University
Lund University
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP