Eighty-six individuals with acute (admission to in-patient rehabilitation) severe
hemiparetic stroke (Chedoke McMaster Stroke Assessment arm score of Stage 2 or 3 out of
7) will participate in this study. All participants will be recruited upon admission to
the Shirley Ryan AbilityLab (formally Rehabilitation Institute of Chicago) for stroke
rehabilitation under the administration of the study physician. Participants will receive
experimental or comparison group therapy as adjuvant to regular in-patient and
day-rehabilitation therapy. Participants will be evaluated weekly while in therapy and
then bimonthly (every other month) after discharge until 1-year following baseline
evaluation.
From the admission evaluations by the study physician and other rehabilitation services,
patients with adequate language, visuospatial, cognitive and motor function will be
consented for participation and then screened by a study evaluation physical therapist
and board-certified neurological clinical specialist for the specific motor inclusion
criteria. After consent, a REDCap screening form will be initiated by the study
physician's project coordinator with relevant data from the participant medical record.
The study evaluation therapist will then conduct the screening that will include
verification and completion of the inclusion/exclusion criteria and the transcranial
magnetic stimulation (TMS) safety checklist that will identify any contraindication to
TMS-based assessment of motor evoked potentials (MEPs). The Chedoke McMaster Stroke
Assessment (primary motor inclusion criteria) is very time efficient reducing
interference with in-patient therapy activities and rapidly identifying individuals with
severe impairment facilitating participant recruitment. The study evaluation therapist
will not need to complete the entire assessment instead only confirming patients at level
2 and 3 out of 7 for inclusion. The REDCap screening form and TMS checklist will be
reviewed by the study physician. The study physician will grant medical clearance for
TMS-based MEP assessment and participation in the study.
Regarding motor criteria; participants not meeting the minimum of Stage 2 out of 7 on the
Chedoke McMaster Stroke Assessment will be monitored for emergence of adequate movement.
Shirley Ryan AbilityLab therapists routinely report Chedoke scores in daily
documentation. The study physician and project coordinator will notify the study
evaluation therapist once minimal movement emerges in these patients and the screening
process can be initiated. Participants who subsequently pass screening and medical
clearance for TMS-based MEP assessment will undergo conventional MEP assessment.
Participants will later be randomly allocated to either the experimental or comparison
treatment groups within REDCap by the study intervention therapist upon the first
intervention session. The REDCap randomization algorithm is managed by the study
biostatistics team and employs a concealed allocation table. The allocation table is
constructed to balance the allocation of participants (2 groups of n=43) by sex, presence
or absence of MEPs, and level of severity as measured by the Fugl-Meyer Arm Motor
Assessment in order to ensure equivalent baseline characteristics of each group. The
Fugl-Meyer score will be divided in bins of 6 points. Participants, evaluation
therapists, biostatisticians, and the study PD/PI will be blinded to group assignment.
Intervention therapists and the study physician will not be blinded to group assignment.
Participants will not be able to tell the difference between interventions since both
will involve reaching practice. Participants that are not medically cleared for TMS-based
MEP assessment will be randomly allocated to group without MEP status. It is anticipated
that only 1-2% of participants will not be cleared for MEP assessment.
Baseline and subsequent evaluations will include a kinematic/kinetic measurement of
reaching function (primary endpoint, reaching distance under standardized abduction
loading, normal gravity) and a kinematic/kinetic measurement of shoulder/elbow impairment
(secondary endpoint, loss of independent joint control). The primary and secondary
endpoints will be conducted at Shirley Ryan AbilityLab during both in-patient and
day-rehabilitation by the study evaluation therapist under following initial training and
certification by the study PD/PI. Standardized clinical evaluations of arm impairment,
activity limitation, and participation restriction will also be performed during this
phase at Shirley Ryan AbilityLab by the study evaluation therapist who will be blinded to
intervention group. Evaluations will take place at baseline, weekly until discharge from
rehabilitation, and then bimonthly until 12 months post-baseline measurement. Following
discharge from rehabilitation, patients will receive follow-up evaluations bimonthly at
Northwestern University Department of Physical Therapy and Human Movement Sciences. These
evaluations will be conducted by a second study evaluation therapist and board-certified
neurological clinical specialist following initial training and certification by the
study PD/PI. The second study evaluation therapist will also serve as the backup for the
first study evaluation therapist in case of illness/absence.
During in-patient rehabilitation and day-rehabilitation, experimental and comparison
intervention sessions will parallel regular therapy and be conducted at Shirley Ryan
AbilityLab and Streeterville Day Rehabilitation Center respectively by two Shirley Ryan
AbilityLab study intervention therapists. Study intervention therapists will be initially
trained and certified by the study PD/PI. Study intervention sessions will be 5 days per
week during in-patient therapy and 3 days per week during day-rehabilitation. The
intervention period for both groups will be ~45 minutes (truncated at 1 hour) in addition
to the regular therapy schedule until discharge. Both interventions will involve
performing standardized reaching exercises to outward targets displayed on a monitor. The
experimental group receiving progressive abduction loading therapy will practice reaching
exercises with abduction loading and the comparison group will practice reaching
supported on a horizontal haptic table. All participants will have the same maximum
number of sets and repetitions of exercise during sessions and the sessions will be
truncated at 60 minutes of total contact time. Half of the enrolled participants are
expected to transition to day-rehabilitation following in-patient rehabilitation. In
day-rehabilitation, participants will continue to receive the same study intervention but
only 3 days per week matching the day-rehabilitation schedule.