Usability Testing of a Bilateral Activities of Daily Exercise Robot for Stroke Therapy

NCT02882646 | Withdrawn

• 1 other identifier: 823898
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In stroke rehabilitation, unilateral training of the impaired limb after stroke is often the frequent strategy used over bilateral ones. However, the clinical need for bilateral training is supported by evidence that shows that unilateral training of the impaired limb does not automatically restore bimanual coordination and function. Increased focused is needed on developing more robot-assisted therapy that can train the impaired arm bilaterally and unilaterally. Controlling these robots is often difficult and requires a better understanding of the coupling effects of the left and right hand before and after a stroke. There is a need to develop robot-assisted therapy devices that can address coupled and uncoupled bimanual movements as well as symmetry as well as asymmetry in context of human bimanual actions along with the intermanual division of labor in various ADL tasks. This study focuses on bilateral training and the use of bio-inspired control algorithms to understand impairment and recovery on Bimanual Activities of Daily Living (ADLs) by stroke subjects in terms of the arm kinematics. Healthy subjects and those with hemiplegia due to a stroke or cerebral palsy will be evaluated by a member of the research team and asked to perform a battery of tasks to test the viability and usability of a bilateral robot system called BiADLER, which allows patients to complete daily tasks with varying levels of assistance to adapt task performance to each individual subject's performance. Subjects will to provide feedback to the researchers on their observations and thoughts about the therapy devices.

Conditions

Stroke; Cerebral Palsy

Keywords

stroke; cerebral palsy; rehabilitation; robotics; therapy; bilateral

Outcome Measures

Primary Outcomes (6)

• Motor Control as assessed by Fugl-Meyer assessment

  Fugl-Meyer assessment will be performed by a physical therapist and will assess motor control of the subject.

  The Fugl-Meyer assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control

• Motor Control as assessed by Box and Block

  The Box and Block assessment will be performed by a member of the study team and will assess motor control by how many blocks that subject is able to move over a barrier.

  The Box and Block assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control

• Motor Control as assessed by Grip Strength

  Grip strength will be measured by a dynamometer which clinically assesses motor control.

  The Grip Strength assessment will be performed during the 1.5 hour long clinical evaluation at the beginning of the study and during the 1.5 hour long clinical evaluation at the conclusion of the study to assess change in motor control

• Bimanual activity quality as assessed by Task Completion Time

  Task Completion Time (TCT): TCT is defined as the time in seconds that it takes to complete the task from initial button press to the final button press.

  In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length

• Bimanual activity quality as assessed by Euclidean Distance

  Euclidean Distance : Relative distance (Euclidean) between the wrists positions of the left (non-dominant) and right (dominant) hands.

  In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length

• Bimanual activity quality as assessed by Ovalization Index

  Ovalization Index : An Ovalization Index (OI) is defined to quantify the occurrence of lateral deviation when continuously drawing a straight vertical line. The strength of any bimanual coupling/interference effect was signaled by an increased OI value in the Non-congruent condition compared to the Congruent condition.

  In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length

Secondary Outcomes (3)

• Phase Difference (PD)

  In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length

• Movement Overlap (MO)

  In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length

• Mean Speed Smoothness

  In Part A, measured during one session, about 1.5 hours in length. For Part B, measured during 12 sessions about 1.5 hours in length

Study Arms (1)

Stroke/CP survivors & healthy subjects

EXPERIMENTAL

Part A: Stroke and CP survivors greater than 18 years of age with hemiplegia and varying levels of impairment. The subject's stroke must have occurred at least 3 months prior to enrollment in the study. Healthy persons over the age of 18 with no upper limb impairment. Part B: Low to mid functioning CP and stroke survivors greater than 18 years of age with hemiplegia. The subject's stroke must have occurred at least 3 months prior to enrollment in the study. All will be asked to use the Bi-ADLER system.

Device: Bi-ADLER

Interventions

Bi-ADLER DEVICE

Subjects will be asked to use the Bi-ADLER for 60 minutes. All subjects will be seated on the Bi-ADLER and asked to perform a battery of bimanual evaluation tasks (creating ovals, standard ADL tasks like pouring, reaching, drinking etc).

Stroke/CP survivors & healthy subjects

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A:
• Stroke and CP survivors greater than 18 years of age with hemiplegia and varying levels of impairment.
• The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
• Healthy persons over the age of 18 with no upper limb impairment.
• Part B:
• Low to mid functioning CP and stroke survivors greater than 18 years of age with hemiplegia.
• The subject's stroke must have occurred at least 3 months prior to enrollment in the study.

You may not qualify if:

• The Montreal Cognitive Assessment (MoCA) to each study participant. After the administration of the MoCA, the PI and research team member will use their to expertise and discretion to determine whether the participant scored well enough on particular components of the MOCA that are of particular concern to this study, e.g. visuospatial acuity and concentration.
• Participants must be able to sit upright for 2 hours at a time in Part A of the study; and 2 hours at a time, 3 days a week, for Part B of the study.
• Participants enrolled in Part B cannot currently be receiving rehabilitation.
• Participants cannot have received Botox injections within the past 3 months.
• Participants cannot be suffering from contractures (chronic loss of joint motion) or debilitating spasticity in the upper extremity or any other neuromuscular disease.
• If a participant is experiencing greater than mild pain, and/or the PI determines that the participant should no longer continue working with the novel therapy devices, the study will be stopped.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine Rittenhouse

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Stroke; Cerebral Palsy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Damage, Chronic

Study Officials

• Michelle J Johnson, PhD

  Penn Medicine Rittenhouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: August 30, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)