Progressive Abduction Loading Therapy
Progressive Abduction Loading Therapy
This study attempts to minimize the development of a common movement impairment following
 stroke known as "flexion synergy" that makes it extremely difficult to reach outward with the
 arm. Participants with acute/subacute stroke will receive one of two study interventions in
 addition to prescribed therapies in both inpatient rehabilitation and day-rehab. Participants
 will be followed for 1 year.
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.
Inclusion Criteria:

 1. Hemiparesis confined to one side, (CMSA Stage 2 or 3 out of 7)

 2. Absence of a brainstem and/or cerebellar lesion

 3. Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment,
 changes in management of hypertension) contraindicating comprehensive in-patient
 rehabilitation

 4. Absence of any acute or chronic painful condition (including hypersensitivity) in the
 upper extremities or spine

 5. Absence of severe aphasia (NIHSS #9, < 2)

 6. Absence of profound extinction and inattention (NIHSS #11, < 2)

 7. Ability to perform a 3-step motor command with the unaffected arm

 8. Capacity to provide informed consent

 9. 21 to 80 years old.