NCT04095338.
Study name | Assistive robotic in the elderly: innovative models in the rehabilitation of the elderly with hip fractures through technological innovation |
Methods | Randomised controlled trial; blinded outcomes assessor |
Participants | Aged 65 or above; traumatic event within 60 days; Functional Ambulation Category score ≤ 2; Ranking scale score ≤ 3; Romberg test: negative; capacity to consent Aim: 195 participants |
Interventions | 1. Experiment (virtual reality game): each session includes 30 minutes of traditional physical rehabilitation plus 20 minutes of virtual robotic training that simulates floor walking and stair climbing 2. Robotic treadmill: each session includes 30 minutes of traditional physical rehabilitation plus 20 minutes of robotic training on a treadmill 3. Control: 50 minutes of traditional physical rehabilitation per session All groups: 2 sessions per week for 5 weeks |
Outcomes | Follow‐up: 24 months post‐intervention Primary outcome: difference in fall risk using the Tinetti Performance‐Oriented Mobility Assessment Secondary outcomes
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Starting date | Study start date: November 2019 Estimated completion date: September 2022 |
Contact information | Roberta Bevilacqua INRCA Research Hospital Ancona, Italy, 60131 00390718004767 r.bevilacqua@inrca.it |
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