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NCT Number: NCT03100201

Robotic-assisted Training After Upper Arm Fracture

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.

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Key information

Conditions

Shoulder Injury Arm Injuries Fractures, Bone Humeral Fractures Shoulder Injuries Wounds and Injuries

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berufsgenossenschaftliche Klinik Ludwigshafen, Ludwigshafen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Armeo®Spring

Other

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

Other

The control group will receive conventional occupational- and physiotherapy over 3 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    WMFT-O is an objective test for assessing the disability of the shoulder

  2. 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

    a goniometer-based measurement of the active range of motion (ROM) of the shoulder joint

  3. 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

    measurement of the grip strength using the Jamar dynamometer

Sponsors and collaborators

Lead sponsor

Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Other

Collaborators

  • BG Unfallklinik Murnau
  • Berufsgenossenschaftliche Unfallklinik Ludwigshafen
  • Deutsche Gesetzliche Unfallversicherung (DGUV)

Registry information

Official study title

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

Acronym: RASTA

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 4, 2017
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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