Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT06169657
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.
Study:
NCT06169657
Study Brief:
Protocol Section:
NCT06169657