Clinical Trials Logo

Clinical Trial Summary

Background: Fingers and wrist functional impairments are common among stroke patients. The patient's engagement, their therapist's engagement, and the patient-therapist interaction during therapy, contribute significantly towards better outcomes in rehabilitation. Music therapeutic interaction between patient and music therapist, which involves active music-making, can enhance a stroke patient's engagement and improve fingers and wrist movement of the affected hand. Study Objectives: 1. To assess the correlation between the therapist engagement's levels, patient engagement's levels, and patient's fingers and wrist movement. 2. To examine how the levels of patient and therapist engagement differ during music therapeutic interaction when compared with verbal interaction. 3. To determine if the changes to patients' fingers and wrist movement differ during a music therapeutic Interaction session when compared with a verbal interaction session. Methods: This feasibility pilot study will include 10 patients, with right-sided hemiparesis who will be recruited 1-6 months following stroke. Each subject will participate in 2 sessions: verbal interaction session and music interactions session conducted both by the same qualified music therapist. For both sessions, each participant will be asked to perform three musical exercises with their right hand on an electric piano. During the Verbal Interaction session, participants will perform exercises alone, while the therapist only interacts with them verbally. During the second session, the Music Therapeutic Interaction session, participants will perform musical exercises while the therapist is interacting with them musically, using music therapy techniques. Measurement tools will include an EEG marker - the Cognitive Effort Index (CEI), for real-time measurement of the patient's and therapist's level of engagement; the HandTutorTM for evaluating real-time changes in a patient's fingers and wrist movement; and video recordings of the patient's hands while performing the musical exercises.


Clinical Trial Description

Background: Fingers and wrist functional impairments are common among stroke patients. The patient's engagement, their therapist's engagement, and the patient-therapist interaction during therapy, contribute significantly towards better outcomes in rehabilitation. Music therapeutic interaction between patient and music therapist, which involves active music making, can enhance a stroke patient's engagement and improve fingers and wrist movement of the affected hand. Study Objectives: 1. To assess the correlation between the therapist engagement's levels, patient engagement's levels and patient's fingers and wrist movement. 2. To examine how the levels of patient and therapist engagement differ during music therapeutic interaction when compared with verbal interaction. 3. To determine if the changes to patients' fingers and wrist movement differ during a music therapeutic Interaction session when compared with a verbal interaction session. Methods Participants: Post stroke rehabilitation patients with right hemiparesis (n=10), recruited 1-6 months following stroke from Reuth Rehabilitation hospital. Recruitment process: The research team will screen patients' records on a daily basis to identify potentially eligible participants. Eligible patients will be invited by the research coordinator to participate in the study. After obtaining informed consent the researcher will meet them for an intake. Sample size: Based on Reuth's electronic medical records, with the assumption that some of the eligible patients will not agree to participate, for this feasibility study a convenience sample of 10 patients will be recruited within two months. Outcome data will be utilized to inform a sample size calculation for the larger study. Study design and procedures This is an intervention study that compares Verbal Interaction to Music Therapeutic Interaction. Each subject will participate in both sessions and will act as their own control, enabling between and within subject comparisons. There will be a two day washout period between the sessions for each patient, to prevent carryover effects. To minimize the between and within subject variance, the sequence of both sessions, including the order of the three musical exercises within each session, will be the same for all study participants. Both sessions will be delivered by the same qualified music therapist with vast clinical experience working with stroke patients in a neurorehabilitation setting. During both sessions, the therapist and the patient will each be wearing single-channel EEG devices to monitor engagement, via the Cognitive Effort Index (CEI) (Neurosky MindWave). Additionally, patients will be wearing a fingers and wrist movement monitoring device on their right affected hand, via the HandTutorTM (MediTouch, Ltd.). Within each session the music therapist's engagement level, the patient's engagement level, and the patient's real-time fingers and wrist movement will be measured. Finally, video recordings of the patient's hands while performing the musical exercises during both interventions will be used to synchronize between the CEI and the HandTutorTM glove. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05011448
Study type Interventional
Source Reuth Rehabilitation Hospital
Contact
Status Terminated
Phase N/A
Start date July 15, 2021
Completion date January 9, 2022

See also
  Status Clinical Trial Phase
Completed NCT04323943 - Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study N/A
Completed NCT05062746 - Immediate Effect of One-session MRT in Hemiparetics N/A
Not yet recruiting NCT05626894 - Novel Wrist Sensor System to Promote Hemiparetic Arm Use in Home Daily Life of Chronic Stroke Survivors Phase 2
Recruiting NCT05399121 - Stroke Patients', Music Therapist' Engagement and Patients' Finger Movement During Music Therapeutic Interaction N/A
Recruiting NCT04620707 - RGS@Home: Personalized 24/7 Home Care Post-stroke N/A
Recruiting NCT06230796 - Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke N/A
Recruiting NCT05809037 - Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke N/A
Recruiting NCT06107010 - Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4) N/A
Active, not recruiting NCT04309266 - The Impact of Robot Assisted Therapy and Metacognitive Skills Training for Children With Hemiparesis N/A
Recruiting NCT05342688 - Contextual Interference, Engagement , and Change in Motor Performance in Stroke Phase 1
Recruiting NCT06362954 - The Relationship Between Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients
Recruiting NCT06109194 - Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke N/A
Recruiting NCT06140381 - Strengthening in Sub-acute Stroke Survivors: A Randomized Controlled Trial N/A
Completed NCT04314830 - Gait Perturbations to Improve Balance Post-stroke N/A
Completed NCT05097391 - Effectiveness of Paretic Lower Limb Loading During Over-ground Training Among Stroke Survivors N/A