Robotic-assisted Training After Upper Arm Fracture (RASTA)

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Injury
• Intervention / Treatment: Other: Intervention Armeo®Spring; Other: Control Group

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ludwigshafen, Germany, 67071
    • Berufsgenossenschaftliche Klinik Ludwigshafen
  • Murnau am Staffelsee, Germany, 82418
    • Berufsgenossenschaftliche Klinik Murnau
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intervention Armeo®Spring; The intervention group will receive conventional occupational- and physiotherapy and an additive robotic-assisted training using the Armeo®Spring robot for three weeks.	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.
ACTIVE_COMPARATOR: Control group; The control group will receive conventional occupational- and physiotherapy.	Other: Control Group; The control group will receive conventional occupational- and physiotherapy over 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH
• Collaborators: Berufsgenossenschaftliche Unfallklinik Ludwigshafen; Deutsche Gesetzliche Unfallversicherung (DGUV); Berufsgenossenschaftliche Unfallklinik Murnau
• Investigators: Study Chair: Peter Augat, Prof., BG Trauma Center Murnau

Publications and helpful links

General 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.
• Nerz 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.
• Nerz 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2016
• Primary Completion (ACTUAL): December 15, 2018
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (ACTUAL): April 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: randomised controlled study; robotic-assisted rehabilitation; humeral fracture
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Shoulder Injuries; Humeral Fractures
• Other Study ID Numbers: RASTA 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No