Robot Aided Rehabilitation - Intervention

Official title

Robot-Aided Diagnosis, Passive-Active Arm Motor and Sensory Rehabilitation Post Stroke: Aims 2&3

Overview

Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.

Detailed description

Sensorimotor impairments following stroke can lead to substantial disability involving the upper extremity. These impairments often involve complex pathological changes across multiple joints and multiple degrees-of-freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. Many potential mechanisms, such as weakness, motoneuronal hyperexcitability, and elevated passive impedance, can contribute and it is currently unclear where to focus treatment. The objectives of this study are to address allocation of therapy resources between the arm and hand and to examine the benefits of combining passive stretching with active movement training.

Aim 1. To compare the efficacy of training the arm versus the hand in promoting upper extremity rehabilitation.

Hypothesis 1: Treating the proximal larger joints in the arm alone will lead to greater improvement than treating the distal hand alone.

Aim 2. To examine the efficacy of combining passive stretching with active (assistive or resistive) training for the shoulder, elbow, wrist, and hand.

Hypothesis 2: Multi-joint intelligent stretching followed by active (assistive or resistive) movement facilitated by use of the IntelliArm arm rehabilitation robot and a Hand rehabilitation robot will improve motor control of the upper extremity more than standard movement therapy alone.

Subjects will be assigned randomly with equal chance to one of four groups. Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Half of all the subjects will be assigned to the stretching groups and the other half to the passive movement groups. Half of the subjects will be assigned to the arm-training and the remaining half to hand-training groups. Arm-training groups will use the IntelliArm, hand-training groups will use the hand robot. For those assigned to the stretching groups, subjects will complete up to 30 minutes of passive stretching with the IntelliArm or the hand robot. For those assigned to the passive movement condition, subjects will do the robot according to their group assignment and wear it for up to 30 minutes with little to no stretching preceding the active therapy session. For each group, the initial about 30 minutes of stretching or relaxing will be followed by 45-60 minutes of active therapy with the IntelliArm or hand robot (depending on group assignment), for a total session time of 75-90 minutes.

The 4 groups of subjects will be compared against each other.

Interventions

• Other Passive stretching
  Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion.
• Other Passive movement
  Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot only within ranges that produce no to very minimal forces.
• Other IntelliArm
  During the active training, subjects will be asked to actively move their arm while supported with IntelliArm robot to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.
• Other Hand robot
  During the active training, subjects will be asked to actively open and close their hand with the hand robot on while participating in task oriented occupational therapy focused on grasp and release tasks. The hand robot may provide resistance or assistance.

Primary outcome measures

• Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points [Time frame: Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention]

Secondary outcome measures (9)

• Changes from baseline Fugl-Meyer Upper Extremity at two time points [Time frame: Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention]
• Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points [Time frame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
• Changes from baseline Modified Ashworth Scale (MAS) at two time points [Time frame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
• Changes from baseline Action Research Arm Test (ARAT) at two time points [Time frame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
• Changes from baseline Grip Strength & Pinch Strength at two time points [Time frame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
• Changes from baseline Nottingham Sensory Assessment at two time points [Time frame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
• Changes from baseline range of motion (ROM) at two time points [Time frame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
• Changes from baseline spasticity at two time points [Time frame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]
• Changes from baseline relaxation time of the finger flexor muscles at two time points [Time frame: Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention]

Eligibility criteria

Inclusion criteria

• First focal unilateral lesion, ischemic or hemorrhagic
• Had a stroke 1-12 months prior to enrollment
• Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand

Exclusion criteria

• Apraxia
• Score of less than 22 on the Mini Mental Status Exam
• Severe pain in the shoulder by a self-rating of 7 out of 10 or greater
• Severe contracture in the upper extremity
• Unable to sit in a chair for 3 consecutive hours
• Unrelated musculoskeletal injuries
• Poor fit into equipment used in study
• Botox injection in upper extremity within 4 months
• Concurrent participation in gait or upper extremity intervention studies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Maryland, Baltimore — Baltimore

Publications

• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, PMID 23239837
• Haggard P, Wing A. Coordinated responses following mechanical perturbation of the arm during prehension. Exp Brain Res. 1995;102(3):483-94. doi: 10.1007/BF00230652. PMID 7737394
• Hoffmann G, Schmit BD, Kahn JH, Kamper DG. Effect of sensory feedback from the proximal upper limb on voluntary isometric finger flexion and extension in hemiparetic stroke subjects. J Neurophysiol. 2011 Nov;106(5):2546-56. doi: 10.1152/jn.00522.2010. Epub 2011 Aug 10. PMID 21832028
• Kamper DG, Harvey RL, Suresh S, Rymer WZ. Relative contributions of neural mechanisms versus muscle mechanics in promoting finger extension deficits following stroke. Muscle Nerve. 2003 Sep;28(3):309-18. doi: 10.1002/mus.10443. PMID 12929190
• Kamper DG, Rymer WZ. Quantitative features of the stretch response of extrinsic finger muscles in hemiparetic stroke. Muscle Nerve. 2000 Jun;23(6):954-61. doi: 10.1002/(sici)1097-4598(200006)23:63.0.co;2-0. PMID 10842274
• Mayer NH, Esquenazi A, Childers MK. Common patterns of clinical motor dysfunction. Muscle Nerve Suppl. 1997;6:S21-35. PMID 9826981
• Shumway-Cook A, Woollacott MH (2001) Motor Control: Theory and Practical Applications, 2nd ed. vol. Chapter 6. Philadelphia: Lippincott Williams & Wilkins.
• Ren Y, Kang SH, Park HS, Wu YN, Zhang LQ. Developing a multi-joint upper limb exoskeleton robot for diagnosis, therapy, and outcome evaluation in neurorehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2013 May;21(3):490-9. doi: 10.1109/TNSRE.2012.2225073. Epub 2012 Oct 19. PMID 23096119

Identifiers

NCT: NCT02359253 · HP-00076764

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗