Clinical trial NCT02410915: A Comparison Between the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training Early After Stroke
Official title: Gait Training Early After Stroke - a Comparison Between Training With the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait, Hemiplegic
Ambulation Difficulty
Hemiparesis
Keywords: Rehabilitation
Robotics
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: University of Tsukuba
First posted: 2015-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on short- and long-term functioning, disability and health compared to conventional gait training as part of an inpatient rehabilitation program early after stroke.

Detailed description: To compare outcome after 4 weeks of gait training with HAL vs. 4 weeks of conventional gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely limited mobility early after stroke.

Study design: Randomized, controlled study with blinded outcome assessment.

Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.

Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.

Eligibility criteria: Inclusion Criteria:

* less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. FAC score 0-1), able to sit on a bench with or-without supervision at least five minutes; sufficient postural control to allow upright position in standing with aids and/or manual support; ability to understand training instructions as well as written and oral study information and to express informed consent; body size compatible with the HAL suit.

Exclusion Criteria:

* contracture restricting gait movements at any lower limb joint; cardiovascular or other somatic condition incompatible with intensive gait training; and severe, contagious infections.

Primary outcomes:
measure: Change in Functional Ambulation Categories (FAC)
timeFrame: Assessed at baseline, after 4 weeks of training and 6 months after stroke
Secondary outcomes:
Other outcomes:
measure: Change in Gait Deviation Index (GDI)
timeFrame: After 4 weeks of training and 6 months after stroke
measure: Change in GDI-kinetic.
timeFrame: After 4 weeks of training and 6 months after stroke
measure: Change in Barthel Index
timeFrame: Assessed at baseline, after 4 weeks of training and 6 months after stroke
measure: Change in Fugl-Meyer for Lower extremities
timeFrame: Assessed at baseline, after 4 weeks of training and 6 months after stroke
measure: Change in Berg Balance scale
timeFrame: Assessed at baseline, after 4 weeks of training and 6 months after stroke
measure: Change in Modified Aschworth scale
timeFrame: Assessed at baseline, after 4 weeks of training and 6 months after stroke
measure: Change in 2 minutes walk test
timeFrame: Assessed at baseline, after 4 weeks of training and 6 months after stroke
measure: Change in Alberts test
timeFrame: Assessed at baseline, after 4 weeks of training and 6 months after stroke
measure: Change in EQ5D
timeFrame: Assessed at baseline, after 4 weeks of training and 6 months after stroke
measure: Stroke impact scale
timeFrame: 6 months after stroke
Locations:
city: Danderyd
country: Sweden
facility: Department of Rehabilitation Medicine, Danderyd Hospital
state: Stockholm
Study officials:
affiliation: Department of Rehabilitation medicine, Danderyd Hospital, Karolinska Institute
name: Jörgen Borg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson A, Vreede KS, Haglund V, Kawamoto H, Sankai Y, Borg J. Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility. J Neuroeng Rehabil. 2014 Jun 2;11:92. doi: 10.1186/1743-0003-11-92.