Shoulder InjuryRASTANCT03100201
Robotic-assisted Training After Upper Arm Fracture
A study testing Intervention Armeo®Spring in people with Shoulder Injury, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Shoulder Injury
- What is being tested?
- Intervention Armeo®Spring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesGermany
- Study dates
- 15 Feb 2016to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgical treatment of the shoulder joint after upper arm fracture classified as type AO 11
- movement-stable fracture
- Inclusion between the fourth and the seventh week after surgery
Who cannot join
- 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)
Show all 9Show fewer
- fractures with involvement of the glenoid cavity
- double fractures
- injury of the plexus or the axillaris nerve
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Berufsgenossenschaftliche Klinik Ludwigshafen
Ludwigshafen, 67071
Berufsgenossenschaftliche Klinik Murnau
Murnau am Staffelsee, 82418
Robert-Bosch-Hospital
Stuttgart, 70376
About this study
Official title: Robotic-assisted Training After Upper Arm Fracture - a Multicentre, Controlled and Randomized Intervention Study
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.
Read the detailed description
60 Patients aged between 35 and 70 years with proximal humeral fracture and surgical treatment will be recruited in three different clinics in Germany and randomised into an intervention and a control group. Participants will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. Baseline assessment will assess cognition (SOMC), level of pain in the affected arm, ability to work, gait speed (10m walk), disability of the arm, shoulder and hand (DASH), as well as the range of motion of the affected arm (goniometer measurement), visual acuity and motor function of orthopaedic patients (WMFT-O). Clinical follow up directly after intervention will assess disability of the arm, shoulder and hand (DASH), the range of motion and motor function (WMFT-O). Primary outcome parameter will be the DASH and secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by a postal follow-up. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.
- Conditions
- Shoulder Injury
- Being tested
- Intervention Armeo®Spring, Control Group
- Keywords
- robotic-assisted rehabilitation, humeral fracture, randomised controlled study
- Medical subject headings
- Shoulder Injuries, Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Armeo®SpringOther
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.
Control GroupOther
The control group will receive conventional occupational- and physiotherapy over 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Armeo®Spring | Active comparator | The intervention group will receive conventional occupational- and physiotherapy and an additive robotic-assisted training using the Armeo®Spring robot for three weeks. Receives: Other: Intervention Armeo®Spring |
| Control group | Active comparator | The control group will receive conventional occupational- and physiotherapy. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disability of the arm, shoulder and hand (DASH)
subjective questionnaire for assessing the disability of the arm, shoulder and hand
Measured: 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-O is an objective test for assessing the disability of the shoulder
Measured: WMFT will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Change in ROM
a goniometer-based measurement of the active range of motion (ROM) of the shoulder joint
Measured: 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
measurement of the grip strength using the Jamar dynamometer
Measured: grip strength will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start15 Feb 2016
- Primary completion15 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be recruited in three different clinics in Germany and randomised into an intervention and a control group. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Sponsor type
- University, hospital or other
- Collaborators
- BG Unfallklinik Murnau, Berufsgenossenschaftliche Unfallklinik Ludwigshafen, Deutsche Gesetzliche Unfallversicherung (DGUV)
- Responsible party
- Principal investigator, Corinna Nerz, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Investigators
- Peter Augat, Prof., Study chair, BG Unfallklinik Murnau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100201
- Sponsor's protocol ID
- RASTA 2016
- Acronym
- RASTA
- Status last verified
- Apr 2020
- First submitted
- 22 Mar 2017
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35727196Nerz 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.
PubMed 31279331Nerz 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.
PubMed 29212528
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-assisted Training After Upper Arm Fracture - a Multicentre, Controlled and Randomized Intervention Study
- ClinicalTrials.gov ID
- NCT03100201
- Acronym / sponsor ID
- RASTA / RASTA 2016
- Conditions
- Shoulder Injury
- Keywords
- robotic-assisted rehabilitation, humeral fracture, randomised controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)University, hospital or other
- Collaborators
- BG Unfallklinik Murnau, Berufsgenossenschaftliche Unfallklinik Ludwigshafen, Deutsche Gesetzliche Unfallversicherung (DGUV)
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
60 Patients aged between 35 and 70 years with proximal humeral fracture and surgical treatment will be recruited in three different clinics in Germany and randomised into an intervention and a control group. Participants will be assessed before randomisation and followed up after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. Baseline assessment will assess cognition (SOMC), level of pain in the affected arm, ability to work, gait speed (10m walk), disability of the arm, shoulder and hand (DASH), as well as the range of motion of the affected arm (goniometer measurement), visual acuity and motor function of orthopaedic patients (WMFT-O). Clinical follow up directly after intervention will assess disability of the arm, shoulder and hand (DASH), the range of motion and motor function (WMFT-O). Primary outcome parameter will be the DASH and secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by a postal follow-up. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be recruited in three different clinics in Germany and randomised into an intervention and a control group. All patients will receive conventional occupational- and physiotherapy. The intervention group will receive an additive robotic-assisted training using the Armeo®Spring robot for three weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention Armeo®Spring | Active comparator | Other: Intervention Armeo®SpringThe 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 comparator | Other: Control GroupThe control group will receive conventional occupational- and physiotherapy. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- surgical treatment of the shoulder joint after upper arm fracture classified as type AO 11
- movement-stable fracture
- Inclusion between the fourth and the seventh week after surgery
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Armeo®SpringThe 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. | Other | Intervention Armeo®Spring |
| Control GroupThe control group will receive conventional occupational- and physiotherapy over 3 weeks | Other | Control group |
Primary outcome
Change in disability of the arm, shoulder and hand (DASH)
Time frame: 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
subjective questionnaire for assessing the disability of the arm, shoulder and hand
3 secondary outcomes
Change in the WMFT-O
Time frame: WMFT will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Change in ROM
Time frame: 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
Time frame: grip strength will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 35727196Handoll 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.
- Derived from this study: PubMed 31279331Nerz 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.
- Derived from this study: PubMed 29212528Nerz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Augat, Prof. study chair
BG Unfallklinik Murnau
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Armeo®Spring in people with Shoulder Injury, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disability of the arm, shoulder and hand (DASH) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03100201, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.