HAL FOR TRAINING OF GAIT EARLY AFTER STROKE Anneli Wall, Reg. Physiotherapist, MSc, PhD student Karolinska Institutet , Department of Clinical Sciences, Danderyd Hospital, KI DS University Department of Rehabilitation Medicine Danderyd Hospital
HAL FOR TRAINING OF GAIT EARLY AFTER STROKE
Anneli Wall, Reg. Physiotherapist, MSc, PhD student Karolinska Institutet , Department of Clinical Sciences, Danderyd Hospital, KI DS University Department of Rehabilitation Medicine Danderyd Hospital
Background
• Limited gait function is common after stroke
• To regain walking ability is often a main goal
• Early, intensive training improves the final outcome
• Electromechanical gait machines may provide this
Gait machines
Gait machines
HAL - Saftey and Feasibility
• 8 patients with stroke > 8 weeks
• 5 days per week
• Autonomous Control and Voluntary Control modes was used.
• No adverse events
• HAL was feasible and safe
Phase I
Nilsson,A.,Vreede,K.S.,Haglund,V.,Kawamoto,H.,Sankai,Y.,Borg,J. (2014). Gait training early after stroke with a new exoskeleton—the hybrid assistive limb: a study of safety and feasibility. J. Neuroeng.Rehabil. 11:92. Grants from: Tsukuba University, Promobilia and STROKE-riksförbundet, Robotdalen.
Authors Diagnosis Included (n) Completed (n)
Kawamoto et al, 2013 Stroke 16 16
Maeshima et al, 2011 Stroke 16 16
Nilsson et al, 2014 Stroke 8 8
Ueba et al, 2013 Stroke 22 6
Watanabe et al, 2014 Stroke 32 22 (11 in each group)
Aach et al, 2014 SCI 8 8
Kubota et al, 2013
Stroke (n= 2) SCI (n=8),
Musculoskeletal diseases (n=4)
Other diseases (n=14)
38 32
Wall A, Borg J and Palmcrantz S (2015). Clinical application of the Hybrid Assistive Limb (HAL) for gait training - a systematic review. Front. Syst. Neurosci. 9:48.
Systematic review confirms: feasibility and safety
Gait training early after stroke – a comparison between training with the exoskeleton Hybrid Assistive Limb and conventional gait training Anneli Wall, PT, MSc, PhD student Susanne Palmcrantz, PT, PhD Vera Häglund, MD Disa Sommerfeld, PT , Associate Professor Katarina Skough Vreede, PT , PhD Jörgen Borg, MD, Professor
Grants from: Tsukuba University, Promobilia, STROKE-riksförbundet, ALF
Phase II
Methods • Inclusion criteria: - less than 8 weeks since stroke onset - inability to walk independently due to lower extremity paresis (FAC 0-1) - sufficient postural control to allow upright position in standing - body size compatible with the HAL suit
Phase II
Methods • Inclusion criteria: - less than 8 weeks since stroke onset - inability to walk independently due to lower extremity paresis (FAC 0-1) - sufficient postural control to allow upright position in standing - body size compatible with the HAL suit • Exclusion criteria: - contractures, cardiovascular or other somatic condition restricting
intensive gait training
Phase II
Training program HAL group Control group
1 session per day 4 days per week 4 weeks Time for each session is individualised but does not exceed 60 min/session (effective time) Training with HAL is performed in combination with body-weight support system and on a treadmill
Conventional gait training, performed according to current practice 5 days a week Approximately 30-60 minutes/session May include use of a treadmill and body weight support
Conventional gait training is offered to both study groups
Phase II
Data Collection ICF* Components
Assessments Baseline Post
intervention 6 months
post stroke
Function • NIH Stroke Scale
• Albert’s test
• Fugl-Meyer Scale
• Modified Ashworth Scale
• Laboratory Gait analysis
- Gait Deviation Index (GDI) and the GDI-kinetic
• Study specific questionnaire
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Activities • Functional Ambulation Categories
• 2 minutes walk test in self-preferred speed
• Berg Balance Scale
• Barthel Index
X
X
X
X
X
X
X
X
X
X
X
X
Activities and participation
• Stroke Impact Scale X
Environmental factor
• Semi-structured interview X
* ICF - International Classification of Functioning, Disability and Health
Phase II
Laboratory gait analysis Phase II
Laboratory gait analysis -motion capture system, force plates
Phase II
Laboratory gait analysis - wireless surface electromyography
Phase II
Baseline Characteristics HAL group Control Group
Number of patients 8 11
Age in mean (SD) 52.1 (12.9) 57 (11.4)
Gender (men/women) 6/2 6/5
Diagnosis (infarct/hemorrhage) 6/2 6/5
Paretic side (left/right) 7/1 6/5
Days from stroke to baseline in mean 30 36
Presence of sensory loss in LE, according to Fugl-Meyer Assessment 8 9
Fugl-Meyer Assessment for LE, motor score, reflexes excluded, 0-28p median (IQR)
3.5 (1.5-8.25)
6.5 (0.75-15.5)
Phase II
Baseline Post
intervention
6 months
post stroke
HAL
(n=8)
Control
(n=11)
HAL
(n=8)
Control
(n=10)
HAL
(n=7)
Control
(n=6)
FAC median
(IQR)
0
(0-1)
0
(0-1)
2
(1.75-3)
2 ,5
(1.25-3)
5
(4-5)
4
(3.25-4.75)
Interim analysis Phase II
Baseline Post
intervention
6 months
post stroke
HAL
(n=8)
Control
(n=11)
HAL
(n=8)
Control
(n=10)
HAL
(n=7)
Control
(n=6)
FAC median
(IQR)
0
(0-1)
0
(0-1)
2
(1.75-3)
2 ,5
(1.25-3)
5
(4-5)
4
(3.25-4.75)
Interim analysis
Score 4
Independent, Level Surfaces Only Independent on level surfaces but requires
supervision/physical assistance in stairs, inclines, or unlevel surfaces.
Phase II
Score 5
Independent, Level and Non-Level Surfaces
Independent on unlevel and level surfaces, stairs, and inclines.
Baseline Post
intervention
6 months
post stroke
HAL
(n=8)
Control
(n=11)
HAL
(n=8)
Control
(n=10)
HAL
(n=7)
Control
(n=6)
FAC median
(IQR)
0
(0-1)
0
(0-1)
2
(1.75-3)
2 ,5
(1.25-3)
5
(4-5)
4
(3.25-4.75)
Interim analysis Phase II
Score 4
Independent, Level Surfaces Only Independent on level surfaces but requires
supervision/physical assistance in stairs, inclines, or unlevel surfaces.
Score 5
Independent, Level and Non-Level Surfaces
Independent on unlevel and level surfaces, stairs, and inclines.
Baseline Post
intervention
6 months
post stroke
HAL
(n=8)
Control
(n=11)
HAL
(n=8)
Control
(n=10)
HAL
(n=7)
Control
(n=6)
2 Minutes Walk Test (meters)
mean
(SD)
5.6
(5.2)
7.7
(13.4)
35.9
(27.4)
40.8
(42.7)
81.9
(56.6)
78.6
(58.5)
Interim analysis Phase II
Baseline Post
Intervention
6 months
post stroke
HAL
(n=8)
Control
(n=11)
HAL
(n=8)
Control
(n=10)
HAL
(n=7)
Control
(n=6)
Berg Balance scale (0-56 p)
median
(IQR)
7.5
(4.8-10.5)
8
(5-14)
18.5
(10-33.3)
20
(14-33.3)
49
(45-52.5)
40
(28-51.3)
Interim analysis Phase II
Baseline Post
intervention
6 months
post stroke
HAL
(n=8)
Control
(n=11)
HAL
(n=8)
Control
(n=10)
HAL
(n=7)
Control
(n=6)
Berg Balance scale (0-56 p)
median
(IQR)
7.5
(4.8-10.5)
8
(5-14)
18.5
(10-33.3)
20
(14-33.3)
49
(45-52.5)
40
(28-51.3)
Interim analysis Phase II
Score of < 45 indicates greater risk of falling
Conclusion Phase II
• HAL shows continued feasibility • HAL allows intensive gait training to start early after stroke • Indicates good results for HAL group and most so at 6 months • Data from the laboratory gait analysis will go in depth on patients walking characteristics
Future study- Phase III • A multicentre, randomized, controlled phase III
study to evaluate HAL training after stroke • Starting in late 2015 • 3 study sites in Sweden
- Danderyd University Hospital, Stockholm - Sahlgrenska University Hospital, Gothenburg - Norrland University Hospital, Umeå
• Two parts - Early after stroke (4-7 weeks), 108 pat - Late/chronic stage (12-48 months), 162 pat
Grants from the Swedish Research Council (VR)
Phase III
Thank you! Researchers Stockholm study group Anneli Wall, RPT, MSc, PhD student Susanne Palmcrantz, RPT, PhD Katarina Vreede, RPT, PhD Disa Sommerfeld, RPT, Associate Professor Lanie Gutierrez-Farewik,Associate Professor Vera Häglund, MD Jörgen Borg, Professor In collaboration with Professor Sankai’s group, Tsukuba Univerity, Japan