Robotic-assisted Training After Upper Arm Fracture

Shoulder Injury Clinical Trial

— RASTA  

Official title:

Robotic-assisted Training After Upper Arm Fracture - a Multicentre, Controlled and Randomized Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100201
• Other study ID #: RASTA 2016
• Status: Completed
• Phase: N/A
• Start date: February 15, 2016
• Est. completion date: December 1, 2019

Study information

• Verified date: April 2020
• Source: Robert Bosch Gesellschaft für Medizinische Forschung mbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 1, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Humeral Fractures
• Shoulder Injuries
• Shoulder Injury

Intervention

Other:
• Intervention Armeo®Spring
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 Group
The control group will receive conventional occupational- and physiotherapy over 3 weeks

Locations

Country	Name	City	State
Germany	Berufsgenossenschaftliche Klinik Ludwigshafen	Ludwigshafen
Germany	Berufsgenossenschaftliche Klinik Murnau	Murnau am Staffelsee
Germany	Robert-Bosch-Hospital	Stuttgart

Sponsors (4)

Lead Sponsor	Collaborator
Robert Bosch Gesellschaft für Medizinische Forschung mbH	Berufsgenossenschaftliche Unfallklinik Ludwigshafen, Berufsgenossenschaftliche Unfallklinik Murnau, Deutsche Gesetzliche Unfallversicherung (DGUV)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the WMFT-O	WMFT-O is an objective test for assessing the disability of the shoulder	WMFT will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Secondary	Change in ROM	a goniometer-based measurement of the active range of motion (ROM) of the shoulder joint	ROM will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change
Secondary	Change in grip strength	measurement of the grip strength using the Jamar dynamometer	grip strength will be assessed before randomisation and followed up after completing an intervention period of 3 weeks for assessing the change

External Links

•   see german clinical trial register