Sensory Re-learning of the Upper Limb After Stroke "SENSUPP"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Control group Other
    Intervention Desc: Traditional task-specific training
    ARM 1: Kind: Experimental
    Label: Control group
    Description: Traditional task-specific training
  • Sensory group Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Sensory group
    Description: Sensory re-learning in combination with task-specific training

Outcomes

Type Measure 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. 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. 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. 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. 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. 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. 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.. Baseline, 5 weeks, 3 month.
Secondary Change in Grippit from baseline to post intervention and from baseline to 3 month follow-up. 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. 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. 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. 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. Baseline, 5 weeks, 3 month.

Sponsors