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Trial · NCT07898150

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryRecruitment RateDuring study enrolmentThe number of participants that consent given the number of potential participants that are approached about the study, expressed as a percentage.
PrimaryIntervention AdherenceCollected at the end of the intervention (Week 4).The number of intervention sessions attended by participants compared to the anticipated number of sessions, expressed as a percentage.
PrimaryAttrition RateCollected at the end of the intervention (Week 4).The number of participants who are withdrawn from the study or drop out, expressed as a percentage of the total sample.
PrimaryAdverse EventsCollected throughout the intervention period with final reporting at the end of the intervention (Week 4).An Adverse Event reporting form will be used to track the number, type, and severity of adverse events. This data will be reported descriptively.
PrimaryFeasibility SurveyCollected at the end of the intervention (Week 4).
All participants will complete a survey about the use of TSS during their therapy. This survey uses a 7-point Likert scale (strongly disagree to strongly agree) to score a total of 13 items, meaning the minimum score would be 13, indicating low feasibility, and the maximum score would be 91, indicating high feasibility. The findings will be reported descriptively.
PrimarySemi-Structured InterviewCollected at the end of the intervention (Week 4).A semi-structured interview will ask participants for their perspectives on the intervention. The data will be reported qualitatively.
SecondarySession TimeCollected throughout the intervention period with final reporting at the end of the intervention (Week 4).Time spent in each session, along with time using TSS. Measured in minutes.
SecondaryDistance TravelledCollected throughout the intervention period with final reporting at the end of the intervention (Week 4).For participants using the FES bike, measured in meters.
SecondaryAsymmetry OutputCollected throughout the intervention period with final reporting at the end of the intervention (Week 4).For participants using the FES bike, measured as percentage of time using the right and left legs.
SecondaryTime Off Motor SupportCollected throughout the intervention period with final reporting at the end of the intervention (Week 4).For participants using the FES bike, measured as percentage of time spent in active compared to passive cycling.
SecondaryEnergyCollected throughout the intervention period with final reporting at the end of the intervention (Week 4).For participants using the FES bike, measured as kilocalories per hour.
SecondaryPowerCollected throughout the intervention period with final reporting at the end of the intervention (Week 4).For participants using the FES bike, measured as average Watts over each session.
SecondaryVelocityCollected throughout the intervention period with final reporting at the end of the intervention (Week 4).For participants using the FES bike, measured as average revolutions per minute (RPM) over each session.
SecondaryStanding and Walking Assessment Tool (SWAT)Collected at baseline and at the end of the intervention (Week 4).For participants in inpatient rehabilitation. Standardized functional scale. Lowest functional stage of 0 (inability to stand) and highest functional stage of 4 (unimpaired community walking).
SecondaryBerg Balance ScaleCollected at baseline and at the end of the intervention (Week 4) as appropriate.
For participants in inpatient rehabilitation in SWAT stages 1-4. Standardized scale with 14 items scored from 0 to 4, with a minimum score of 0, indicating the lowest level of function, and a maximum score of 52, indicating the highest functional level.
SecondaryModified Timed-Up-and-GoCollected at baseline and at the end of the intervention (Week 4) as appropriate.For participants in inpatient rehabilitation in SWAT stages 2-4. Measured in time taken to complete (seconds).
Secondary10 Meter Walk TestCollected at baseline and at the end of the intervention (Week 4) as appropriate.For participants in inpatient rehabilitation in SWAT stages 2-4. Measured in time taken to complete which is converted to walking speed (meters per second).
SecondarySix Minute Walk TestCollected at baseline and at the end of the intervention (Week 4) as appropriate.For participants in inpatient rehabilitation in SWAT stages 3-4. Measured in total distance walked (meters).
SecondaryActivities-specific Balance Confidence ScaleCollected at baseline and at the end of the intervention (Week 4) as appropriate.
For participants in inpatient rehabilitation in SWAT stages 2-4. Standardized scale with 16 items scored from 0 to 100 and then averaged, with a minimum score of 0, indicating the lowest level of confidence, and a maximum score of 100, indicating the highest confidence level.
SecondaryManual Muscle TestingCollected at baseline and at the end of the intervention (Week 4).
For participants in inpatient rehabilitation. Standardized scale with 16 muscles scored from 0 (no muscle activation) to 5 (full strength against resistance) bilaterally. Total scores for the upper and lower extremity summed.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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