Sensory Re-learning of the Upper Limb After Stroke

NCT ID: NCT03336749

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2021-02-04

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sensory group

Sensory re-learning in combination with task-specific training

Group Type: EXPERIMENTAL

Sensory group

Intervention Type: BEHAVIORAL

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.

Control group

Traditional task-specific training

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

Traditional task-specific training

Interventions

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.

Intervention Type: BEHAVIORAL

Control group

Traditional task-specific training

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Christina Brogardh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Brogårdh

Role: PRINCIPAL_INVESTIGATOR

Department of Health Sciences, Faculty of Medicine, Lund University

Locations

Skåne University Hospital

Lund, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 34225764 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29665842 (View on PubMed)

Other Identifiers

Sensory

Identifier Type: -

Identifier Source: org_study_id