Crossmodal Learning in Therapeutic Processes (Task 2-1)

NCT05262699 | Suspended

• 1 other identifier: SFB TRR 169/A3 (2-1)
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke.

Conditions

Stroke

Keywords

Vibro-tactile stimulation; Neurorehabilitation; Stroke

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Action Research Arm Test (ARAT)

  The Action Research Arm Test (ARAT) is a 19 item observational measure to assess upper extremity performance (coordination, dexterity and functioning). Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores may range from 0-57 points, with higher points indicating better performance.

  One day before (baseline) and one day after seven days of motor training

• Change from baseline in Nine-hole peg Test (NHPT)

  A timed measure of fine manual dexterity where the patient is instructed to first take nine pegs out of a container and place them afterwards back into the empty holes of the container as quickly as possible.

  One day before (baseline) and one day after seven days of motor training

Secondary Outcomes (4)

• Change from baseline in Fugl-Meyer Assessment for upper extremity (FMA-UE)

  One day before (baseline) and one day after seven days of motor training

• Change from baseline in Stroke Impact Scale (SIS)

  One day before (baseline) and one day after seven days of motor training

• Change from baseline in National Institutes of Health Stroke Scale (NIHSS)

  One day before (baseline) and one day after seven days of motor training

• Change from baseline in Modified Rankin Scale (mRS)

  One day before (baseline) and one day after seven days of motor training

Study Arms (2)

Stimulation

EXPERIMENTAL

During motor training participants in the stimulation arm receive vibro-tactile feedback applied to their fingers when touching an object as measured by force-sensing resistors mounted to the fingertips.

Device: Vibro-tactile stimulation

Control

PLACEBO COMPARATOR

The control group receives the same motor training with the same derives (force-sensing resistors, vibro-tactile stimulators) mounted to the hands but receives no stimulation.

Other: Placebo Control

Interventions

Vibro-tactile stimulation DEVICE

Vibro-tactile stimulation will be administered to the fingers of the participants via C3 tactors (diameter: 2.03 cm, height: 0.64 cm, operating frequency: 180-320 Hz, see https://www.eaiinfo.com/tactor-info/). Vibro-tactile stimulation will be triggered by force-sensing resistors (TEA CAPTIV T-SENS FSR, see https://www.teaergo.com/products/tea-captiv-t-sens-fsr/).

Stimulation

Placebo Control OTHER

Devices mounted, no stimulation

Control

Eligibility Criteria

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

You may qualify if:

• Ischemic stroke according to ICD 10 I61-I69
• Age \>= 18, \<=80
• Existing declaration of consent

You may not qualify if:

• Pregnancy
• Lacking capacity for consent

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• German Research Foundation: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf, Neurologie

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessment, motor training, data analyzes, and group allocation are done by different persons. Participants as well as the assessor, the trainer and the investigator are blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: March 2, 2022
• Study Start: April 14, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 24 months after main publication.
• Access Criteria: Personal login into UKE data repository.

Locations

DE (1)