Effects of robot-assisted treadmill training in combination with resistance exercise on locomotor performance and quality of life as well as cardiovascular and neuromuscular properties in patients after stroke and individuals with spinal cord injury.

Effects of robot-assisted treadmill training in combination with resistance exercise on locomotor performance and quality of life as well as cardiovascular and neuromuscular properties in patients after stroke and individuals with spinal cord injury. - Lokomat and resistance exercise after stroke and spinal cord injury.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32398

Enrollment

120

Registered

2008-03-17

Start date

2008-11-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dwarslaesie cerebrovascular accident spinal cord lesion stroke

Interventions

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 physica

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The time at the 10m walk test will be used as the primary outcome variable to assess walking performance.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)