Robotic-assisted Training After Upper Arm Fracture
RASTA
1 other identifier
interventional
48
1 country
3
Brief Summary
In this study, patients with upper arm fracture will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks on the injured arm in addition to conventional physio- and occupational therapy. The supportive treatment and execution of specific exercises on the Armeo®Spring should lead to improved recovery of function and mobility of the upper arm compared to conservatively treated patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2016
CompletedFirst Submitted
Initial submission to the registry
March 22, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 24, 2020
April 1, 2020
2.8 years
March 22, 2017
April 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in disability of the arm, shoulder and hand (DASH)
subjective questionnaire for assessing the disability of the arm, shoulder and hand
DASH will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months for assessing the change
Secondary Outcomes (3)
Change in the WMFT-O
WMFT will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Change in ROM
ROM will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Change in grip strength
grip strength will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Study Arms (2)
Intervention Armeo®Spring
ACTIVE COMPARATORThe intervention group will receive conventional occupational- and physiotherapy and an additive robotic-assisted training using the Armeo®Spring robot for three weeks.
Control group
ACTIVE COMPARATORThe control group will receive conventional occupational- and physiotherapy.
Interventions
The robotic-assisted training will be performed using the clinically evaluated Armeo®Spring medical device (Hocoma AG, Zurich, Switzerland). By means of a sensory orthosis, arm movements will be supported and transmitted to a computer system and visually shown on a screen.
The control group will receive conventional occupational- and physiotherapy over 3 weeks
Eligibility Criteria
You may qualify if:
- surgical treatment of the shoulder joint after upper arm fracture classified as type AO 11
- movement-stable fracture
You may not qualify if:
- limited cognition as defined by a score in Short-Orientation-Memory-Concentration Test (SOMC) less than 10 points
- inadequate level of pain during movement of the affected shoulder joint (pain score \>5 on a visual analogue pain scale)
- strongly limited vision or hearing
- heart failure (New York Heart Association stage III-IV) or COPD (Chronic Obstructive Pulmonary Disease) Gold stage III-IV
- walking speed \<0.8m/sec
- isolated tuberculum majus fracture of the humerus (AO 11, A1)
- fractures with involvement of the glenoid cavity
- double fractures
- injury of the plexus or the axillaris nerve
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Berufsgenossenschaftliche Klinik Ludwigshafen
Ludwigshafen, 67071, Germany
Berufsgenossenschaftliche Klinik Murnau
Murnau am Staffelsee, 82418, Germany
Robert-Bosch-Hospital
Stuttgart, 70376, Germany
Related Publications (3)
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PMID: 35727196DERIVEDNerz C, Schwickert L, Scholch S, Gordt K, Nolte PC, Kroger I, Augat P, Becker C. Inter-rater reliability, sensitivity to change and responsiveness of the orthopaedic Wolf-Motor-Function-Test as functional capacity measure before and after rehabilitation in patients with proximal humeral fractures. BMC Musculoskelet Disord. 2019 Jul 6;20(1):315. doi: 10.1186/s12891-019-2691-0.
PMID: 31279331DERIVEDNerz C, Schwickert L, Becker C, Studier-Fischer S, Mussig JA, Augat P. Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial. Trials. 2017 Dec 6;18(1):589. doi: 10.1186/s13063-017-2274-z.
PMID: 29212528DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter Augat, Prof.
BG Unfallklinik Murnau
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research associate
Study Record Dates
First Submitted
March 22, 2017
First Posted
April 4, 2017
Study Start
February 15, 2016
Primary Completion
December 15, 2018
Study Completion
December 1, 2019
Last Updated
April 24, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share