Clinical trial NCT06169657: Comparison of Gait Training Methods in Sub-acute Stroke and Spinal Cord Injury
Official title: Comparison of Intensity and Step Count of Gait Training Modalities in the Inpatient Rehabilitation Setting in Sub-acute Central Nervous System Injury
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Incomplete Spinal Cord Injury
Keywords: Stroke
Incomplete Spinal Cord Injury
Gait Rehabilitation
Exoskeleton
Balance
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals poststroke or post-iSCI that are inpatients at Shirley Ryan AbilityLab

Brief summary: The purpose of the project is to compare intensity (minutes in target heart rate zone) and steps per session across three gait training modalities, including body-weight supported treadmill training (BWSTT), overground gait training with body weight-support (BWS), and overground gait training utilizing a lower extremity exoskeleton, between patients presenting with varying functional ambulation capacities in the inpatient setting. Additionally, the researchers will compare physical therapist (PT) burden across these modalities and patient functional presentation levels.

Detailed description: Aim 1 of this study is to measure stepping repetition and intensity via heart rate of three gait-training modalities utilized with patients in the subacute phase of stroke and iSCI during inpatient rehabilitation in order to guide therapists through clinical decision-making of selecting the optimal intervention for patients based on functional presentation. Aim 2 of this study is to measure therapist burden across each gait training modalities, as this is an additional factor that contributes to the number of steps taken and intensity experienced by the patient.

The gait training modalities assessed will include BWSTT, overground gait training with a lower extremity exoskeleton, and overground gait training with BWS. The participants' functional level will be classified by gait speed obtained via the 10 meter walk test (10MWT), a standardized assessment commonly used in rehabilitation. These functional classification categories include household ambulator (low level) and limited community ambulator (high level), determined by Fritz et al. 2009.

The researchers hypothesize that low functioning/household ambulators will achieve more minutes in high-intensity training zones utilizing the exoskeleton due to the enhanced participation and increased weight-bearing the device supports compared to the other modalities. In addition, a greater number steps will be achieved in this mode due to the exoskeleton's ability to decrease overall therapist burden compared to BWSTT and overground with BWS. In contrast, the researchers anticipate that steps per session and overall intensity will be decreased in high functioning/limited community ambulators due the unnecessary support the exoskeleton provides at this functional level. The researchers believe that high functioning/ limited community ambulators will achieve the highest number of steps and intensity during BWSTT due to the ability to increase challenges via treadmill parameters such as speed and incline while utilizing a harness for safety and bodyweight support only as necessary. In contrast, the researchers believe the amount of BWS and assistance a PT must provide relative to the patient's contribution to practice successful stepping during BWSTT will result in a lower intensity and number of steps achieved in low functioning/household ambulators.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years old, inclusive
* Medical clearance from primary medical team (signed Medical Clearance form)
* Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c
* Gait speed between 0-0.79 m/s
* Informed consent provided by participant or POA
* English speaking

Additional Inclusion Criteria for patients post-stroke:

* First stroke, ischemic or hemorrhagic, within the past six months
* Unilateral, supratentorial stroke

Additional Inclusion Criteria for patients iSCI:

* ASIA C or D
* Traumatic iSCI, within past six months

Exclusion Criteria

* Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally
* History of or concurrent neurologic condition (i.e., stroke, SCI, PD, TBI, MS, etc.)
* History of peripheral nerve injury
* Severe knee, hip, or ankle osteoarthritis
* Severe osteoporosis as indicated by physician medical clearance
* Open wounds on skin surfaces in contact with exoskeleton or harness
* Unstable spine or unhealed fractures
* Weight bearing precautions
* Unresolved deep vein thrombosis (DVT)
* Pregnancy
* Prisoners

Additional Exclusion criteria for EksoNR13:

* Weight \>220 lbs (100 kg)
* Height below 60 inches or above 76 inches
* Standing hip width of approximately 18 inches or more
* Joint contractures or range of motion deficits that limit normal range of motion during ambulation:

  * Knee flexion contracture greater than 12°
  * Hip flexion contracture greater than 17°
  * Inability to achieve 0° neutral ankle dorsiflexion with knee flexion up to 12°
  * Bilateral hip flexion less than 110°
* Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
* Leg length discrepancy:

  * Greater than 0.5 in. (1.27 cm) for upper legs
  * Greater than 0.75 in. (1.91 cm) for lower legs
* Active heterotopic ossification
* Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
* High anxiety or claustrophobia
* Clostridium difficile or other gastrointestinal isolation precautions
* Colostomy
* Uncontrolled autonomic dysreflexia
* Lower limb prosthesis

Primary outcomes:
measure: Observation of Step count
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of Time spent in age-predicted maximum high-intensity target heart rate zone
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of Time spent in age-predicted moderate-intensity target heart rate zone
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of Time spent in age-predicted low-intensity target heart rate zone
timeFrame: Each session through completion of study, up to 10 days
Secondary outcomes:
measure: Observation of Minutes spent in equipment setup per session
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of Minutes spent in rest breaks per session
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of Minutes spent stepping
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of Patient Borg Rating of perceived exertion (RPE)
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of Patient Intrinsic Motivation Inventory (IMI)
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of therapist maximum heart rate
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of therapist maximum Borg Rating of perceived exertion (RPE)
timeFrame: Each session through completion of study, up to 10 days
measure: Observation of therapist Numerical Pain Rating Scale (NPRS)
timeFrame: Each session through completion of study, up to 10 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Jose L Pons, PhD
role: PRINCIPAL_INVESTIGATOR
References: