Robot Mediated Therapy-Feasibility Study and Preliminary Effects

NCT05729633 | Unknown

• 1 other identifier: 202301-00007
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to investigate the feasibility of the application of robot mediated impairment-training (RMIT) and robot mediated task-specific training (RMTT) in acute stroke patients with upper limb impairments. The main question\[s\] it aims to answer are:

• Is it feasible and safe to conduct RMIT and RMTT in acute stroke patients with upper limb impairments?
• What are the preliminary effects on the physical function and quality of life in these patients? Participants will undergo 20 hours of robot mediated upper limb therapy. Researchers will compare RMIT with RMIT+RMTT to see if there are any differences in the effects on physical function and quality of life.

Conditions

Stroke

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 score indicates better outcome)

  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

Other: Robot mediated upper limb therapy

Robot mediated impairment-orientyed 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

Other: Robot mediated upper limb therapy

Interventions

Robot mediated upper limb therapy OTHER

The OR is classified as a Class A device with the Health Sciences Authority. The OR is capable of both 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-orientyed 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 (investigating adult stroke patients)

You may not qualify if:

• Fractures or other musculoskeletal issues that render the use of the robotic device unsuitable
• Involvement in another concurrent upper limb study
• Wounds that do not allow donning of the device
• Severe spasticity
• Cognitive impairment (MMSE ≤20)
• Inability to follow instructions
• Severe osteoporosis
• Infectious 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

+6569366455; tay.san.san@singhealth.com.sg

Edmund Neo, MBBS

CONTACT

69366462; Edmund.Neo.Jin.Rui@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 enrol patients to the trial will be distinct and kept separate from the study team member that open the sealed envelopes and perform group assignment We will establish procedures to maintain separation between study team members that assess the outcomes, and those that perform group assignment. At the start of every assessment, 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: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 15, 2023
• Study Start: February 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share