Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-12-06

AUTHORS

Corinna Nerz, Lars Schwickert, Clemens Becker, Stefan Studier-Fischer, Janina Anna Müßig, Peter Augat

ABSTRACT

BACKGROUND: The incidence of proximal humeral fractures increases with age. The functional recovery of the upper arm after such fractures is slow, and results are often disappointing. Treatment is associated with long immobilisation periods. Evidence-based exercise guidelines are missing. Loss of muscle mass as well as reduced range of motion and motor performance are common consequences. These losses could be partly counteracted by training interventions using robot-assisted arm support of the affected arm derived from neurorehabilitation. Thus, shorter immobilisation could be reached. Thus far, this approach has been tested in only a few small studies. The aim of the present study is to examine whether assistive robotic training augmenting conventional occupational and physical therapy can improve functional shoulder outcomes. METHODS/DESIGN: Patients aged between 35 and 66 years with proximal humeral fracture and surgical treatment will be recruited at three different clinics in Germany and randomised into an intervention group and a control group. Participants will be assessed before randomisation and followed after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. The baseline assessment will include cognition (Short Orientation-Memory-Concentration Test); level of pain in the affected arm; ability to work; gait speed (10-m walk); disability of the arm, shoulder and hand (Disabilities of the Arm, Shoulder and Hand Outcome Measure [DASH]); range of motion of the affected arm (goniometer measurement); visual acuity; and motor function of orthopaedic patients (Wolf Motor Function Test-Orthopaedic version [WMFT-O]). Clinical follow-up directly after the intervention will include assessment of disability of the arm, shoulder and hand (DASH) as well as range of motion and motor function (WMFT-O). The primary outcome parameter will be the DASH, and the secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by postal follow-up. All patients will receive conventional occupational and physical therapy. The intervention group will receive additional robot-assisted training using the Armeo®Spring robot for 3 weeks. DISCUSSION: This study protocol describes a phase II, randomised, controlled, single-blind, multicentre intervention study. The results will guide and possibly improve methods of rehabilitation after proximal humeral fracture. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03100201 . Registered on 28 March 2017. More... »

PAGES

589

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s13063-017-2274-z

DOI

http://dx.doi.org/10.1186/s13063-017-2274-z

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1099703433

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29212528


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37 schema:description BACKGROUND: The incidence of proximal humeral fractures increases with age. The functional recovery of the upper arm after such fractures is slow, and results are often disappointing. Treatment is associated with long immobilisation periods. Evidence-based exercise guidelines are missing. Loss of muscle mass as well as reduced range of motion and motor performance are common consequences. These losses could be partly counteracted by training interventions using robot-assisted arm support of the affected arm derived from neurorehabilitation. Thus, shorter immobilisation could be reached. Thus far, this approach has been tested in only a few small studies. The aim of the present study is to examine whether assistive robotic training augmenting conventional occupational and physical therapy can improve functional shoulder outcomes. METHODS/DESIGN: Patients aged between 35 and 66 years with proximal humeral fracture and surgical treatment will be recruited at three different clinics in Germany and randomised into an intervention group and a control group. Participants will be assessed before randomisation and followed after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. The baseline assessment will include cognition (Short Orientation-Memory-Concentration Test); level of pain in the affected arm; ability to work; gait speed (10-m walk); disability of the arm, shoulder and hand (Disabilities of the Arm, Shoulder and Hand Outcome Measure [DASH]); range of motion of the affected arm (goniometer measurement); visual acuity; and motor function of orthopaedic patients (Wolf Motor Function Test-Orthopaedic version [WMFT-O]). Clinical follow-up directly after the intervention will include assessment of disability of the arm, shoulder and hand (DASH) as well as range of motion and motor function (WMFT-O). The primary outcome parameter will be the DASH, and the secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by postal follow-up. All patients will receive conventional occupational and physical therapy. The intervention group will receive additional robot-assisted training using the Armeo®Spring robot for 3 weeks. DISCUSSION: This study protocol describes a phase II, randomised, controlled, single-blind, multicentre intervention study. The results will guide and possibly improve methods of rehabilitation after proximal humeral fracture. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03100201 . Registered on 28 March 2017.
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45 DASH
46 Germany
47 NCT03100201
48 Secondary outcome parameters
49 Spring robot
50 WMFT
51 ability
52 acuity
53 additional robot-assisted training
54 age
55 aim
56 approach
57 arm
58 arm support
59 assessment
60 assessment of disability
61 assistive robotic training
62 baseline assessment
63 clinic
64 cognition
65 common consequence
66 consequences
67 control group
68 conventional rehabilitation
69 different clinics
70 disability
71 effectiveness
72 evidence-based exercise guidelines
73 exercise guidelines
74 fractures
75 function
76 functional recovery
77 functional shoulder outcomes
78 group
79 guidelines
80 hand
81 humeral fractures
82 immobilisation
83 immobilisation period
84 incidence
85 intervention
86 intervention group
87 intervention period
88 intervention studies
89 level of pain
90 levels
91 long immobilisation periods
92 long-term results
93 loss
94 mass
95 method
96 methods of rehabilitation
97 months
98 motion
99 motor function
100 motor performance
101 multicentre intervention study
102 multicentre trial
103 muscle mass
104 neurorehabilitation
105 orthopaedic patients
106 outcome parameters
107 outcomes
108 pain
109 parameters
110 participants
111 patients
112 performance
113 period
114 phase II
115 physical therapy
116 present study
117 primary outcome parameter
118 protocol
119 proximal humeral fractures
120 randomisation
121 range
122 range of motion
123 recovery
124 rehabilitation
125 results
126 robot
127 robot-assisted arm support
128 robot-assisted training
129 robotic training
130 shorter immobilisation
131 shoulder outcomes
132 small study
133 speed
134 study
135 study protocol
136 such fractures
137 support
138 surgical treatment
139 therapy
140 training
141 training intervention
142 treatment
143 trials
144 upper arm
145 visual acuity
146 weeks
147 years
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