Sensory Re-learning of the Upper Limb After Stroke

Stroke Clinical Trial

— SENSUPP  

Official title:

SENSory Re-learning of the UPPer Limb After Stroke (SENSUPP): a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336749
• Other study ID #: Sensory
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: February 4, 2021

Study information

• Verified date: February 2021
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 4, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 5 weeks, 3 months.
Primary	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.	Baseline, 5 weeks, 3 months.
Primary	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.	Baseline, 5 weeks, 3 months.
Primary	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.	Baseline, 5 weeks, 3 months.
Secondary	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.	Baseline, 5 weeks, 3 month.
Secondary	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.	Baseline, 5 weeks, 3 month.
Secondary	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.	Baseline, 5 weeks, 3 month.
Secondary	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).	Baseline, 5 weeks, 3 month.
Secondary	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).	Baseline, 5 weeks, 3 month.
Secondary	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.	Baseline, 5 weeks, 3 month.
Secondary	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).	Baseline, 5 weeks, 3 month.
Secondary	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.	Baseline, 5 weeks, 3 month.