Sensory Re-learning of the Upper Limb After Stroke

NCT03336749 | Completed

• 1 other identifier: Sensory
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke, upper limb, sensory training, rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (8)

• 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.

• 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.

• 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.

• Change in Grippit from baseline to post intervention and from baseline to 3 month follow-up.

  Baseline, 5 weeks, 3 month.

• Changes in Motor Activity Log (MAL) from baseline to post intervention and from baseline to 3 month follow-up.

  Baseline, 5 weeks, 3 month.

Study Arms (2)

Sensory group

EXPERIMENTAL

Sensory re-learning in combination with task-specific training

Behavioral: Sensory group

Control group

ACTIVE COMPARATOR

Traditional task-specific training

Other: Control group

Interventions

Sensory group 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.

Sensory group

Control group OTHER

Traditional task-specific training

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• at least 6 months since stroke onset
• be able to walk with or without an assistive device

You may not qualify if:

• sensory impairments of the UL due to other diagnosis than stroke

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Skåne University Hospital

Lund, Sweden

Location

Related Publications (2)

• 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.

  PMID: 34225764 DERIVED

• 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.

  PMID: 29665842 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Christina Brogårdh

  Department of Health Sciences, Faculty of Medicine, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors are blinded to the participants' group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 8, 2017
• Study Start: April 1, 2017
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

SE (1)