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

Primary Purpose

Stroke, Stroke, Acute, Cerebral Vascular Accident

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BURT
Other Occupational Therapy
Sponsored by
Sunnyview Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring BURT, Upper extremity function, Inpatient rehabilitation, Upper extremity robotics

Eligibility Criteria

18 Years - 115 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inpatient at Sunnyview Rehabilitation Hospital
  • >/= 18 years
  • Unilateral stroke affecting dominant side
  • 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.

Sites / Locations

  • Gaylord Hospital
  • Sunnyview Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Upper Extremity Neuroeducation

BURT Upper Extremity

Arm Description

74 patients will receive the standard occupational therapy sessions that they would normally receive during their IRF stay. UE neuroeducation sessions are typically focused on improving strength and mobility of the upper arm. Clinicians will not be given instructions on how to run their sessions, however they will not be allowed to use BURT. Other devices that would normally be used during neuro-educational sessions (including X-cite, electrical stimulation and RT-300) will be allowed for use in this group. The therapists will track the activity, level of assistance and time provided in a tracking sheet, as well as document any adverse events that may occur

As part of routine therapy, 74 patients will receive up to 5 sessions per week of BURT UE therapy in place of conventional neuro re-education. Patients in this arm of the study will receive any conventional therapy during the remainder of their treatment sessions. When using BURT, therapists will track the activity, level of assistance and time provided in a tracking sheet, as well as document any adverse events that may occur.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Modified Ashworth Scale (MAS)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
Modified Ashworth Scale (MAS)
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
9 Hole Peg Test (9HPT)
The 9HPT is a standardized test that measures manual dexterity.
9 Hole Peg Test (9HPT)
The 9HPT is a standardized test that measures manual dexterity.

Secondary Outcome Measures

GG Scores for Self-Care Items
standardized assessments of functional independence for feeding, bathing, toileting, footwear, upper and lower body dressing and oral hygiene.
GG Scores for Mobility items
standardized assessments of functional independence for bed mobility and transfers.

Full Information

First Posted
May 10, 2022
Last Updated
February 15, 2023
Sponsor
Sunnyview Rehabilitation Hospital
Collaborators
Gaylord Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05401799
Brief Title
BURT Efficacy in Improving Upper Extremity Strength and Function During Post-stroke Inpatient Rehabilitation
Official Title
Efficacy of the Barrett Upper Extremity Robot (BURT) for Improving Upper Extremity Strength and Function During Inpatient Rehabilitation Following Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnyview Rehabilitation Hospital
Collaborators
Gaylord Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Acute, Cerebral Vascular Accident, Cerebral Vascular Accident (CVA)/Stroke
Keywords
BURT, Upper extremity function, Inpatient rehabilitation, Upper extremity robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Upper Extremity Neuroeducation
Arm Type
Active Comparator
Arm Description
74 patients will receive the standard occupational therapy sessions that they would normally receive during their IRF stay. UE neuroeducation sessions are typically focused on improving strength and mobility of the upper arm. Clinicians will not be given instructions on how to run their sessions, however they will not be allowed to use BURT. Other devices that would normally be used during neuro-educational sessions (including X-cite, electrical stimulation and RT-300) will be allowed for use in this group. The therapists will track the activity, level of assistance and time provided in a tracking sheet, as well as document any adverse events that may occur
Arm Title
BURT Upper Extremity
Arm Type
Experimental
Arm Description
As part of routine therapy, 74 patients will receive up to 5 sessions per week of BURT UE therapy in place of conventional neuro re-education. Patients in this arm of the study will receive any conventional therapy during the remainder of their treatment sessions. When using BURT, therapists will track the activity, level of assistance and time provided in a tracking sheet, as well as document any adverse events that may occur.
Intervention Type
Device
Intervention Name(s)
BURT
Intervention Description
Use of Barrett Upper extremity Robot (BURT) to improve strength and mobility of hemiplegic upper extremity.
Intervention Type
Procedure
Intervention Name(s)
Other Occupational Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
UE Motor Assessment Scale (UE-MAS)
Description
Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.
Time Frame
T2(Day 20-23) - T0 (Day 4-6)
Title
UE Motor Assessment Scale (UE-MAS)
Description
Used to assess motor functions in the affected upper extremity following a stroke. This evaluation uses task-oriented techniques instead of isolated movement patterns.
Time Frame
T1 (Day 12-14) - T0 (Day 4-6)
Title
Manual Muscle Testing (MMT)
Description
Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.
Time Frame
T2(Day 20-23) - T0 (Day 4-6)
Title
Manual Muscle Testing (MMT)
Description
Used to assess the strength in a persons upper extremity based on various planes of movement. This is the most commonly used strength assessment.
Time Frame
T1 (Day 12-14) - T0 (Day 4-6)
Title
Modified Ashworth Scale (MAS)
Description
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
Time Frame
T2(Day 20-23) - T0 (Day 4-6)
Title
Modified Ashworth Scale (MAS)
Description
The modified Ashworth Scale is the primary measure for muscle spasticity in the upper extremities for patients with neurological conditions.
Time Frame
T1 (Day 12-14) - T0 (Day 4-6)
Title
9 Hole Peg Test (9HPT)
Description
The 9HPT is a standardized test that measures manual dexterity.
Time Frame
T2(Day 20-23) - T0 (Day 4-6)
Title
9 Hole Peg Test (9HPT)
Description
The 9HPT is a standardized test that measures manual dexterity.
Time Frame
T1 (Day 12-14) - T0 (Day 4-6)
Secondary Outcome Measure Information:
Title
GG Scores for Self-Care Items
Description
standardized assessments of functional independence for feeding, bathing, toileting, footwear, upper and lower body dressing and oral hygiene.
Time Frame
Change from admission to discharge, up to 55 days
Title
GG Scores for Mobility items
Description
standardized assessments of functional independence for bed mobility and transfers.
Time Frame
Change from admission to discharge, up to 55 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
115 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Teale, PhD
Phone
518-386-3613
Email
amy.teale@sphp.com
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Harmon, PhD
Phone
518-382-4520
Email
erin.harmon@sphp.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Casey Cowan, MS OTR/L
Organizational Affiliation
Sunnyview Rehabilitation Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily Steenburgh, MS OTR/L
Organizational Affiliation
Sunnyview Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaylord Hospital
City
Wallingford
State/Province
Connecticut
ZIP/Postal Code
06492
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
Sunnyview Rehabilitation Hospital
City
Schenectady
State/Province
New York
ZIP/Postal Code
12308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Teale, PhD
Phone
518-386-3613
Email
amy.teale@sphp.com
First Name & Middle Initial & Last Name & Degree
Erin Harmon, PhD
Phone
518-382-4520
Email
erin.harmon@sphp.com
First Name & Middle Initial & Last Name & Degree
Casey Cowan, MS OTR/L
First Name & Middle Initial & Last Name & Degree
Emily Steenburgh, MS OTR/L

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Barrett_Medical. Robotic Assist Rehabilitation Made Easy. https://medical.barrett.com/
Results Reference
background
Citation
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.
Results Reference
background
Citation
Figueiredo S ZL. 2011. Modified Ashworth Scale. https://strokengine.ca/en/assessments/modified-ashworth-scale/
Results Reference
background
Citation
Figueiredo S. 2011. Nine Hole Peg Test (NHPT). https://strokengine.ca/en/assessments/nine-hole-peg-test-nhpt/
Results Reference
background

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

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