Robot Mediated Therapy-Upper Limb Outcomes in Stroke

NCT05805644 | Unknown

• 1 other identifier: ChangiGH1
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine the clinical outcomes of stroke patients who are provided with adjunctive robot-mediated task specific therapy(RMTT) and robot-mediated impairment training (RMIT) as compared to those who are provided with adjunctive RMIT.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Change of FMA-UE(Fugl Meyer Assessment for Upper Extremity) from baseline

  30 items assessing motor function and 3 items assessing reflex function (0-66, higher scores indicates better outcomes)

  baseline, 1 month and 3 months post commencement of intervention

Secondary Outcomes (10)

• Change of FMA-UA( Fugl Meyer Assessment-Upper Arm) from baseline

  baseline, 1 month and 3 months post commencement of intervention

• Change of FMA-W/H (Fugl Meyer Assessment- Wrist/Hand) from baseline

  baseline, 1 month and 3 months post commencement of intervention

• Change of FAT( Frenchay Arm Test) from baseline

  baseline, 1 month and 3 months post baseline

• Change of FIM (Functional Independence Measure) from baseline

  baseline, 1 month, 3 months post baseline

• Change of MMT( manual muscle testing) from baseline

  baseline, 1 month and 3 months post baseline

Study Arms (2)

Robot mediated Impairment-oriented training(RMIT)

EXPERIMENTAL

Participant receives 20 hours of robot mediated impairment-oriented training applied via the Optimo Regen

Device: Robot mediated upper limb therapy

Robot mediated impairment-oriented and task-specific training (RMIT+RMTT)

EXPERIMENTAL

Participant receives a total of 20 hours of robotic therapy. 10 hours will be in the form of RMIT and 10 hours in the form of RMTT

Device: Robot mediated upper limb therapy

Interventions

Robot mediated upper limb therapy DEVICE

The OR is classified as a Class A device with the Health Sciences Authority. The OR is capable of delivering RMIT as well as RMTT. It can provide zero, partial or full assistance to the patient to complete the movement or task. Its teach-and-follow mode allows a movement to be performed by the therapist, with the device then "replaying" the movement at either zero, partial or full assistance for the patient. Impairment oriented training will focus on the following movements: 1. Diagonal movement 2. Shoulder abduction 3. Shoulder adduction 4. Shoulder flexion 5. Shoulder extension 6. Elbow flexion 7. Elbow extension Task-specific training will focus on the following activities: 1. Picking up a cup/glass by the side and drink 2. Brushing hair 3. Cleaning unaffected upper limb (hand to arm) 4. Wiping table 5. Wiping wall 6. Sliding card on table to a designated location 7. Clipping a clothe peg

Robot mediated Impairment-oriented training(RMIT); Robot mediated impairment-oriented and task-specific training (RMIT+RMTT)

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stroke as evidenced by CT/MRI findings
• First-ever stroke (ischaemic or haemorrhagic)
• Upper limb weakness and an FMA-UE score of 16-53 (severe to moderate: 16-34. moderate to mild: 35-53)12,13
• Cognitively intact to follow instructions
• Medically stable to participate
• Consent given
• Age 21 and above

You may not qualify if:

• \. Fractures or other musculoskeletal issues that render the use of the robotic device unsuitable 2. Involvement in another concurrent upper limb study 3. Wounds that do not allow donning of the device 4. Severe spasticity 5. Cognitive impairment (MMSE ≤20) 6. Inability to follow instructions 7. Severe osteoporosis 8. Infectious diseases that require the patient to be isolated in a single room eg airborne diseases

Sponsors & Collaborators

• Changi General Hospital: lead

Related Publications (3)

• Conroy SS, Wittenberg GF, Krebs HI, Zhan M, Bever CT, Whitall J. Robot-Assisted Arm Training in Chronic Stroke: Addition of Transition-to-Task Practice. Neurorehabil Neural Repair. 2019 Sep;33(9):751-761. doi: 10.1177/1545968319862558. Epub 2019 Jul 22.

  PMID: 31328671 RESULT

• Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

  PMID: 30175845 RESULT

• Hung CS, Hsieh YW, Wu CY, Lin KC, Lin JC, Yeh LM, Yin HP. Comparative Assessment of Two Robot-Assisted Therapies for the Upper Extremity in People With Chronic Stroke. Am J Occup Ther. 2019 Jan/Feb;73(1):7301205010p1-7301205010p9. doi: 10.5014/ajot.2019.022368.

  PMID: 30839256 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

San San Tay, MBBS

CONTACT

69366455; tay.san.san@singhealth.com.sg

Edmund Neo, MBBS

CONTACT

69366462; neo.jin.rui.edmund@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: To prevent subversion of the allocation sequence, study team members who enroll patients to the trial will be distinct and kept separate from the study team member that perform the randomization. We will establish the procedures to maintain separation between study team members that assess the outcomes, and those that perform group assignment. At the start of every assignment, patients will be reminded to not reveal their treatment assignment by referring to elements of the treatment that are unique to their treatment group. Functional outcome scales are performed by blinded therapists who work in the unit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: June 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share