The primary objective is to explore the effect on Donning and Doffing of REACTION and their subsystems (ABLE REGAIN and GABLE CORE) in individuals with neurological disorders. The secondary goals include: 1. To explore the effect of REACTION and…
ID
Source
Brief title
Condition
- Other condition
- Central nervous system vascular disorders
Synonym
Health condition
patients with lower extremity limitations due to trauma-related injuries and/or neurologic disorders
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is DONNING and DOFFING
Secondary outcome
Secondary outcomes are:
- Gait speed
- kinematic data
- Short Form Berg Balance Scale (SFBBS)
- Short Falls Efficacy Scale - International
- Level of Assistance
Background summary
Neurological disorders, such as stroke and spinal cord injury (SCI), can affect
our ability to walk and balance. Robotic devices in rehabilitation might train
walking and balance capabilities in patients with neurological disorders.
Recent papers and reviews have highlighted the potential of various control
strategies during walking, such as assist-as-needed (AAN). A new robotic
assisted balance and gait trainer (REACTION) will be designed to train walking
and balance in patients with neurological disorders. REACTION is one of the
first modular ambulatory balance and gait trainer that combines
assist-as-needed (AAN) balance on the affected leg and provide body-weight
support
Study objective
The primary objective is to explore the effect on Donning and Doffing of
REACTION and their subsystems (ABLE REGAIN and GABLE CORE) in individuals with
neurological disorders. The secondary goals include:
1. To explore the effect of REACTION and their subsystems on gait speed
2. To explore the effect of REACTION and their subsystems on gait kinematics
3. To explore the effect of REACTION and their subsystems on balance
4. To explore the effect of REACTION and their subsystems on user satisfaction
Study design
Multicenter feasibility study
Intervention
Two measurement days consisting of a walking and balance tasks for each
condition (no aid, regular aid, ABLE REGAIN, GABLE CORE, REACTION). The
condition 'regular aid' does not have a balance task.
Study burden and risks
During the clinical tests there is a chance that subjects might lose their
balance. However, the tasks that are performed during these measurements
resemble tasks of daily life and short versions of commonly used balance tests
in conventional rehabilitation. Therefore, the chances that performing these
tasks will lead to falls are not higher compared to daily life. In addition,
all included participants are independent walkers (FAC 3-4) and an investigator
always walk beside the participant while performing all tasks. Gait analysis
involves no extra risks to walking in daily life. Subjects can take rest
between the measurements any time they like.
Roessinghsbleekweg 33B
Enschede 7522AH
NL
Roessinghsbleekweg 33B
Enschede 7522AH
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a participant must meet
all of the following criteria:
• Age > 16 years
• Able to give informed consent
• Weight < 90 kg
Stroke patients:
• first-ever ischemic or haemorrhagic stroke
• FAC score between 3 and 4
• (Sub)acute or chronic phase
SCI patients:
• Neurological injury levels ranging from C5 to T9
• Motor incomplete spinal cord injury (ASIA impairment score of C or D)
• Able to walk independently (without physical support)
Exclusion criteria
A potential participant who meets any of the following criteria will be
excluded from participation in this study:
• mild to severe cognitive problems
• Premorbid disability of lower extremity
• Skin lesions or severely impaired sensation at the hemiparetic leg
• Contraindication for mobilization, like lower limb fracture
• Insufficient knowledge of the Dutch language to understand the purpose or
methods of the study
• Pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06805500 |
| CCMO | NL88875.044.25 |