Usability Testing of a Bilateral Activities of Daily Exercise Robot for Stroke Therapy (BiADLER)
연구 개요
상세 설명
Subjects may be video-taped or photographed in any of the following sessions.
Part A: Participation in this part of the study will include the following steps:
1) Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
2a) Pre-Assessments: A member of the research team will evaluate the subjects' affected arm and assess their ability to use it. Subjects will be evaluated using a battery of assessments in order to determine their level of impairment such as the Upper Extremity Fugl-Meyer, Montreal Cognitive Assessment, Box in Block, and grip strength using a dynamometer, etc.
2b) Break: Subjects will be given a 15 minute break.
2c) Subjects will be asked to use the Bilateral Activities of Daily Living Exercise Robot (Bi-ADLER) for 60 minutes. All subjects will be seated on the Bi-ADLER and asked to perform a battery of bimanual evaluation tasks (drawing ovals, standard ADL tasks like pouring, reaching, drinking etc). A total of three trials (each 1 min or less) will be done for each evaluation task and a 5 min break will be given after two tasks. His/her kinematic data while performing the corresponding evaluation task will be compared against the healthy baseline to predict their level of impairment. During this portion of the experiment, the controller will provide no assistance to the patient. This will take a total of about 25-30 mins. After the the controller will be engaged and assistance will be provided to patients for performing the same battery of tasks completed in the first half of this session. This will take another 25-30 mins.
Part B: For subjects invited to participate in Part B of the study - only low to mid functioning Cerebral Palsy (CP) and stroke survivors are eligible -participation in this part of the study will include the following steps:
1) Informed Consent: After arrival, subjects will review and sign the consent form with study personnel present.
2a) Pre-Assessments: If subjects are only participating in Part B of the study, at their first visit, a member of the research team will evaluate their affected arm and assess their ability to use it. Subjects will be evaluated using a battery of assessments in order to determine their level of impairment such as the Upper Extremity Fugl-Meyer, Montreal Cognitive Assessment, Box in Block and grip strength using a dynamometer, etc. If a study subject participated in Part A, they will not be reevaluated by a therapist as long as evaluation was done within a month of Part B.
2b) Break: Subjects will be given a 15 minute break. 2c) Bi-ADLER training with the robot for 50-60 minutes. In this part of the protocol, the subject will come to the lab for about 10-12 sessions. In each session, the subject performs different activities of daily Living tasks (like pouring, drinking etc) on the Bi-ADLER for about 50-60 mins with a 5 min break every15 mins. This part is contingent on the subject having completed Part A of the protocol. During the final session (between 10th - 12th session), the same battery of tasks as in Part A will be performed by the subject. There will also be a clinical evaluation at the end of that session to evaluate clinical scores.
3) Post-Study Assessment: After their last session, a certified therapist will evaluate the participants' affected arm and assess their ability to use it.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19146
- Penn Medicine Rittenhouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Stroke/CP survivors & healthy subjects
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. |
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).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Motor Control as assessed by Fugl-Meyer assessment
기간: 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
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Fugl-Meyer assessment will be performed by a physical therapist and will assess motor control of the subject.
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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
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Motor Control as assessed by Box and Block
기간: 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
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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.
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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
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Motor Control as assessed by Grip Strength
기간: 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
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Grip strength will be measured by a dynamometer which clinically assesses motor control.
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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
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Bimanual activity quality as assessed by Task Completion Time
기간: 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
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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.
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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
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Bimanual activity quality as assessed by Euclidean Distance
기간: 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
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Euclidean Distance : Relative distance (Euclidean) between the wrists positions of the left (non-dominant) and right (dominant) hands.
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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
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Bimanual activity quality as assessed by Ovalization Index
기간: 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
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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.
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Phase Difference (PD)
기간: 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
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PD describes the lag between the two limbs as a measure of the synchronization of the two arms.
Thus, a positive PD signifies that the dominant arm was leading in the task.
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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
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Movement Overlap (MO)
기간: 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
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MO is defined as the time when both hands were in motion as a percentage of total TCT
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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
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Mean Speed Smoothness
기간: 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
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Smoothness was calculated by counting the number of peaks in the velocity profile.
The greater the value, the poorer the quality of the movement.
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michelle J Johnson, PhD, Penn Medicine Rittenhouse
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Bi-ADLER에 대한 임상 시험
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Boehringer Ingelheim완전한
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Boehringer Ingelheim완전한
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Boehringer Ingelheim완전한
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Boehringer Ingelheim완전한