SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial

Abstract

Background: Many stroke survivors suffer from sensory impairments of their affected upper limb (UL). Although such impairments can affect the ability to use the UL in everyday activities, very little attention is paid to sensory impairments in stroke rehabilitation. The purpose of this trial is to investigate if sensory re-learning in combination with task-specific training may prove to be 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.

Methods/design: This study is a single-blinded pilot randomized controlled trial (RCT) with two treatment arms. The participants will be randomly assigned either to sensory re-learning in combination with task-specific training (sensory group) or to task-specific training only (control group). The training will consist of 2.5 h of group training per session, 2 times per week for 5 weeks. The primary outcome measures to assess sensory function are as follows: Semmes-Weinstein monofilament, Shape/Texture Identification (STI™) test, Fugl-Meyer Assessment-upper extremity (FMA-UE; sensory section), and tactile object identification test. The secondary outcome measures to assess motor function are as follows: Box and Block Test (BBT), mini Sollerman Hand Function Test (mSHFT), Modified Motor Assessment Scale (M-MAS), and Grippit. To assess the ability to use the hand in daily activities, perceived participation, and life satisfaction, the Motor Activity Log (MAL), Canadian Occupational Performance Measure (COPM), Stroke Impact Scale (SIS) participation domain, and Life Satisfaction checklist will be used. Assessments will be performed pre- and post-training and at 3-month follow-up by independent assessors, who are blinded to the participants' group allocation. At the 3-month follow-up, the participants in the sensory group will also be interviewed about their general experience of the training and how effective they perceived the training.

Discussion: The results from this study can add new knowledge about the effectiveness of sensory re-learning in combination with task-specific training on UL functioning after stroke. If the new training approach proves efficient, the results can provide information on how to design a larger RCT in the future in persons with sensory impairments of the UL after stroke.

Trial registration: ClinicalTrials.gov, NCT03336749 . Registered on 8 November 2017.

Keywords: Rehabilitation; Sensory re-learning; Stroke; Upper limb.

Conflict of interest statement

Ethics approval and consent to participate

Prior to inclusion in the study, all participants will receive verbal and written information, and signed written informed consent will be required to participate. The study has been approved by the Regional Ethical Review Board in Lund Sweden (Dnr 2017/7). The principles of the Declaration of Helsinki will be adhered to.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Flow chart of the study design

Fig. 2

SPIRIT figure of enrollment, interventions, and outcome measures. Abbreviations: SWM Semmes-Weinstein monofilament, STITM Shape/Texture Identification, FMA-UE Fugl-Meyer Assessment—upper extremity, BBT Box and Block Test, mSHFT mini Sollerman Hand Function Test, M-MAS Modified Motor Assessment Scale, MAL Motor Activity Log, COPM Canadian Occupational Performance Measure, SIS Stroke Impact Scale