The primary objective of the SCI and to investigate its effectiveness on locomotor performance, participation and quality of life. The proposed study further aims to assess the time course of effects, not only during the training period, but also…
ID
Source
Brief title
Condition
- Other condition
- Cranial nerve disorders (excl neoplasms)
Synonym
Health condition
dwarslaesie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The time at the 10m walk test will be used as the primary outcome variable to
assess walking performance.
Secondary outcome
Additional outcome variables for functional performance are time to perform
*get-up-and-go* test; score at Berg Balance Scale; Functional Ambulation
Categories-score; Rivermead Mobility Index; distance walked at 6-min Walk test.
Scores at the questionnaires SS-QOL, RAND-36/SF-36 will be used for assessment
of quality of life and scores at the SIP68 will be used for assessment of
social participation.
Variables for cardiovascular function are maximal power output, VO2 and heart
rate during a graded exercise test.
Variables of lower limb muscle function include strength and rate of torque
development during maximal voluntary contractions and (submaximal) electrically
evoked contractions and fatigue resistance will be assessed with repeated
electrically evoked contractions.
Background summary
Stroke and spinal cord injury (SCI) leads to severe disability. Many patients
have difficulties in performing daily life activities, such as walking or
climbing stairs, leading to reduced participation (i.e. *involvement in life
situations*) and quality of life. Therefore, an important part of
rehabilitation programs in persons after stroke and (incomplete) SCI is aimed
at restoration of gait function. There is a growing scientific support for the
importance of task specific training in patients with neurological disorders.
In addition, because muscle strength of the lower limbs seems to be closely
associated with locomotor performance in these patients, additional resistance
exercise of these muscles may be important. It is hypothesized that a
combination of robot-assisted treadmill training with resistance training will
lead tot significantly greater improvement of locomotor performance,
participation and quality of life of stroke patients and individuals with
incomplete SCI than regular occupational and physical therapy care.
Study objective
The primary objective of the SCI and to investigate its effectiveness on
locomotor performance, participation and quality of life. The proposed study
further aims to assess the time course of effects, not only during the training
period, but also during follow-up after cessation of the training. Finally, it
aims to assess the underlying proposed study is to construct a specific
training program for stroke patients and persons with incomplete cardiovascular
and neuromuscular mechanisms which may be associated with these effects.
Study design
A randomized controlled trial
Intervention
Patients will be assigned to either a control group or to one of two
experimental groups. All patients (experimental as well as control groups) will
receive similar standard occupational and physical therapy care, except for the
gait training module which is part of this rehabilitation program. One
experimental group will receive a specific (gait) training program consisting
of 2-3 weekly robot-assisted treadmill training sessions with a Lokomat robotic
gait orthosis. The second experimental group also will receive the
aforementioned lokomat-training, however, interspersed with a weekly bilateral
lower limb resistance training session. This treadmill training (with or
without additional resistance exercise) will substitute for the regular gait
training module the subjects in the control group will receive.
Study burden and risks
Subjects will participate in a 9-months research project executing a 12 week
training-program of robot-assisted treadmill training 2-3 days/week,
interspersed with a weekly bilateral lower limb resistance training session.
Measurements will be performed at maximal 10 different time slots including
tests that assess locomotor performance and cardiovascular and neuromuscular
function (45 min to 1.5 hours of duration) as well as questionnaires for social
participation and quality of life. Subject may experience some discomfort
during electrical stimulation and/or muscle soreness after muscle tests.
Furthermore, the risks during training and testing sessions are relatively low
because of thorough screening prior to participation, use of skilled and
licensed therapists and safety precautions throughout training and testing. The
expected beneficial training effects in combination with the limited risks
would justify execution of the proposed study.
v/d Boechorststr. 9
1081 BT Amsterdam
NL
v/d Boechorststr. 9
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
CVA
- first ever stroke (ischaemic, hemorarghic)
- hemiparesis (at least lower limb)
- min. age: 18 yrs
SCI
- motor incomplete lesion (ASIA C, D)
- paraplegia (at least lower limb)
- min age: 18 yrs.
All patient must be incapable to walk unaided.
Exclusion criteria
- medical complications such as unstable hypertension-
arrhythmias and unstable cardiovascular problems
- severe skeletal problems such as osteoarthritis of the lower limbs.
- severe cognitive and/or communicative problems, preventing ability to follow verbal instructions
- earlier neurological and/or psychiatric problems
- other problems that would limit the ability to perform the requested tasks
- contra-indications for electrical stimulation (unstable epilepsy, cancer, skin abnormalities, pacemaker).
Design
Recruitment
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 |
|---|---|
| CCMO | NL22052.029.08 |