Efficacy of REMO Training for Hand Motor Recovery After Stroke

NCT05815368 | Recruiting DMC

• 1 other identifier: 2021.13
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Upper limb motor impairment is one of the most common sequelae after stroke. Indeed, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation. In the last years, new approaches in neurorehabilitation field has been investigated to enhance motor recovery. The use of wearable devices combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. Moreover, sEMG is used to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. The aim of the study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke. A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment and sEMG will be collected during 12 hand movements. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare muscle activation with a normal reference model.

Conditions

Stroke; Stroke, Ischemic; Stroke Hemorrhagic; Stroke Sequelae

Keywords

Neurological Rehabilitation; Surface Electromyography; Upper Extremity; Motor Impairment; Biofeedback; Motor Recovery

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity - hand

  Fugl-Meyer Upper Extremity - hand section is a specific section of Fugl-Meyer Upper Extremity assessment that assesses the wrist and hand motor function in patients with post-stroke hemiplegia. There are 3 values:0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0. The maximum value is 24 points, which corresponds to normal hand motor function.

  Change from Baseline Fugl-Meyer Upper Extremity (hand items) at 3 weeks

Secondary Outcomes (13)

• Fugl-Meyer Upper Extremity

  Change from Baseline Fugl-Meyer Upper Extremity at 3 weeks

• Fugl-Meyer Assessment - sensation

  Change from Baseline Fugl-Meyer Assessment (sensation) at 3 weeks

• Fugl-Meyer Assessment - pain and Range of Motion

  Change from Baseline Fugl-Meyer Assessment (pain and Range of Motion) at 3 weeks

• Box and Blocks Test

  Change from Baseline Box and Blocks Test at 3 weeks

• Reaching Performance Scale

  Change from Baseline Reaching Performance Scale at 3 weeks

Other Outcomes (1)

• sEMG activation

  Change from Baseline sEMG muscle activation at 3 weeks

Study Arms (2)

REMO training

EXPERIMENTAL

REMO training will consist of sEMG-biofeedback exercises provided by REMO device.

Device: REMO

Task-Oriented training

ACTIVE COMPARATOR

Task-Oriented training will consist of task-specific functional exercises

Other: Task-Oriented Training

Interventions

REMO DEVICE

REMO training will consist of sEMG-biofeedback exercises provided by REMO device. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.

REMO training

Task-Oriented Training OTHER

Task-Oriented training will consist of task-specific functional exercises. The training will be provided 1 hour a day, for 5 days/week, for totally 3 weeks.

Task-Oriented training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single ischemic or haemorrhagic stroke
• Fugl-Meyer Upper Extremity score: minimum 10/66 points

You may not qualify if:

• Major depressive disorder;
• Fractures;
• Traumatic Brain Injury;
• Severe Ideomotor Apraxia;
• Severe Neglect;
• Severe impairment of verbal comprehension.

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS San Camillo Hospital

Venice-Lido, Venice, 30126, Italy

RECRUITING

Related Publications (5)

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

  PMID: 35363499 BACKGROUND

• Parker J, Powell L, Mawson S. Effectiveness of Upper Limb Wearable Technology for Improving Activity and Participation in Adult Stroke Survivors: Systematic Review. J Med Internet Res. 2020 Jan 8;22(1):e15981. doi: 10.2196/15981.

  PMID: 31913131 BACKGROUND

• Di Girolamo M, Celadon N, Appendino S, Turolla A. and Ariano P. EMG-based biofeedback system for motor rehabilitation: A pilot study,. IEEE Biomedical Circuits and Systems Conference (BioCAS). 2017; pp. 1-4, doi: 10.1109/ BIOCAS.2017.8325086.

  BACKGROUND

• D. Rimini et al.,

  BACKGROUND

• Pregnolato G, Rimini D, Baldan F, Maistrello L, Salvalaggio S, Celadon N, Ariano P, Pirri CF, Turolla A. Clinical Features to Predict the Use of a sEMG Wearable Device (REMO(R)) for Hand Motor Training of Stroke Patients: A Cross-Sectional Cohort Study. Int J Environ Res Public Health. 2023 Mar 14;20(6):5082. doi: 10.3390/ijerph20065082.

  PMID: 36981992 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Giorgia Pregnolato

  IRCCS San Camillo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgia Pregnolato

CONTACT

+0412207; giorgia.pregnolato@hsancamillo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical assessments will be performed before and after the treatment by a physical therapist not involved in training and blinded to the purpose and group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory of Healthcare Innovation Technology

Model Details: Randomized-Controlled Trial (RCT)

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 18, 2023
• Study Start: October 4, 2022
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

IT (1)