BURT Efficacy in Improving Upper Extremity Strength and Function During Post-stroke Inpatient Rehabilitation

Stroke Clinical Trial

Official title:

Efficacy of the Barrett Upper Extremity Robot (BURT) for Improving Upper Extremity Strength and Function During Inpatient Rehabilitation Following Stroke.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05401799
• Other study ID #: 22-0324-1
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Sunnyview Rehabilitation Hospital
• Contact: Amy Teale, PhD
• Phone: 518-386-3613
• Email: amy.teale[@]sphp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Barrett Upper Extremity Robot (BURT) is an FDA-approved upper extremity robot that assists patients with both passive and active range of motion while providing adjustable resistance (Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/). Activities are directed by therapists and encourage patient involvement through video game activities providing active proprioceptive, vibrational, visual and auditory feedback. Engaging and colorful games are beneficial in holding patients' interest, and gravity assistance may also allow for increased repetition in the face of patient fatigue. In this prospective study, the investigators will determine if a standardized BURT Upper Extremity (UE) program can be consistently implemented within an acute inpatient rehabilitation facility (IRF). In addition, the investigators will see if patients who receive BURT have improved UE mobility and function as a result. The investigators will also study the perceived enjoyment and value of the intervention by patients, and perceived value by therapists. Because BURT therapy is able to provide more repetitions of upper extremity movement in a shorter length of time than conventional therapy, the investigators hypothesize that patients who participate in neuro re-education activities using BURT will achieve greater improvements in strength, upper extremity function, fine motor coordination, activities of daily living and mobility during their time in an IRF than patients receiving conventional therapy. In this study, eligible patients admitted to Sunnyview Rehabilitation Hospital (SRH) for rehabilitation following stroke will be randomized to receive conventional or BURT therapy. Meaningful clinical benchmarks for upper extremity function, tone, fine motor coordination, activities of daily living and mobility will be assessed using the Upper Extremity Motor Assessment Scale (UE-MAS)(Zelter, 2010), manual muscle testing (MMT), Modified Ashworth Scale (MAS) (Figueiredo, 2011) and the 9-hole peg test (9HPT)(Figueiredo, 2011). The investigators also hypothesize that patients in the BURT cohort will report greater value/usefulness and interest/enjoyment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 115 Years

Eligibility

Inclusion Criteria:

• Inpatient at Sunnyview Rehabilitation Hospital
• >/= 18 years
• Unilateral stroke
• UE paresis affected arm with 3-/5 or less manual muscle testing throughout Exclusion Criteria: >30 days post stroke
• Severe Neglect
• Bilateral stroke
• Prior stroke with residual deficits
• Patients receiving prism adaptation treatment
• Comorbid neurological disorders
• Upper limb comorbidities that could limit functional improvement (UE arthritis pain, UE fracture, fixed contracture not allowing for proper device alignment)
• Severe shoulder subluxation that cannot be accommodated by the device
• Severe osteoporosis
• Unable to follow simple directions
• Unable to tolerate sitting 30 minutes
• Expected length of stay (LOS) < 15 days.

Related Conditions & MeSH terms

• Cerebral Vascular Accident
• Stroke
• Stroke, Acute

Intervention

Device:
• BURT
Use of Barrett Upper extremity Robot (BURT) to improve strength and mobility of hemiplegic upper extremity.

Procedure:
• Other Occupational Therapy
Standard occupational therapy sessions will be 60-90 minutes a day and are UE neuroeducation sessions are typically focused on improving strength and mobility of the hemipelagic arm.

Locations

Country	Name	City	State
United States	Sunnyview Rehabilitation Hospital	Schenectady	New York
United States	Gaylord Hospital	Wallingford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Sunnyview Rehabilitation Hospital	Gaylord Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/

Figueiredo S ZL. 2011. Modified Ashworth Scale. https://strokengine.ca/en/assessments/modified-ashworth-scale/

Figueiredo S. 2011. Nine Hole Peg Test (NHPT). https://strokengine.ca/en/assessments/nine-hole-peg-test-nhpt/

Zelter L. 2010. Motor Assessment Scale (MAS). https://strokengine.ca/en/assessments/motor-assessment-scale-mas/#:~:text=The%20Motor%20Assessment%20Scale%20(MAS,leakage%20from%20a%20blood%20vessel.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UE Motor Assessment Scale (UE-MAS)	Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.	T2(Day 20-23) - T0 (Day 4-6)
Primary	UE Motor Assessment Scale (UE-MAS)	Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.	T1 (Day 12-14) - T0 (Day 4-6)
Primary	Manual Muscle Testing (MMT)	Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.	T2(Day 20-23) - T0 (Day 4-6)
Primary	Manual Muscle Testing (MMT)	Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.	T1 (Day 12-14) - T0 (Day 4-6)
Primary	Modified Ashworth Scale (MAS)	The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.	T2(Day 20-23) - T0 (Day 4-6)
Primary	Modified Ashworth Scale (MAS)	The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.	T1 (Day 12-14) - T0 (Day 4-6)
Primary	9 Hole Peg Test (9HPT)	The 9HPT is a standardized test that measures manual dexterity.	T2(Day 20-23) - T0 (Day 4-6)
Primary	9 Hole Peg Test (9HPT)	The 9HPT is a standardized test that measures manual dexterity.	T1 (Day 12-14) - T0 (Day 4-6)
Secondary	GG Scores for Self-Care Items	standardized assessments of functional independence for feeding, bathing, toileting, footwear, upper and lower body dressing and oral hygiene.	Change from admission to discharge, up to 55 days
Secondary	GG Scores for Mobility items	standardized assessments of functional independence for bed mobility and transfers.	Change from admission to discharge, up to 55 days