The quality of walking after LOPES II training.

Efficacy of Assist-As-Needed (AAN) robotic gait training in sub-acute stroke survivors.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26996

Enrollment

Registered

2015-02-13

Start date

2015-03-01

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Stroke robotic gait training quality Assist-as-needed CVA robot looptraining kwaliteit ondersteuning-naar-behoefte

Interventions

Experimental group recieves LOPES II training 3 times a week, complemented with maximal 2 times conventional gait training, based on preset goals (determined during gait analysis). The control group

Eligibility

Inclusion criteria

Inclusion criteria: - adults (> 18 years of age) with a first-ever unilateral ischemic or haemorrhagic supratentorial stroke - time since stroke between 4 and 6 weeks - a Functional Ambulation Category (FAC) 3 or larger (walking with or without supervision or walking aid) - impaired quality of gait related to one of the five possible training goals (efficiency, stability in stance, foot clearance, foot prepositioning and step length) - stable cardiopulmonary and general medical condition - Mini Mental State Examination > 22 - Sufficient communication ability (Utrechts Communicatie Onderzoek > 2) - Signed informed consent

Exclusion criteria

Exclusion criteria: - Insufficient mastery of the Dutch language - Serious orthopaedic disorders interfering with gait - Other neurological disorders or interfering disorders - Depressed mood (Hospital Anxiety and Depression Scale > 7) - No independent ambulation prior to stroke - Chronic (joint) pain - Severe spasticity interfering with robotic support - Inappropriate or unsafe fit of the robotic trainer due to extreme body size (bodyweight > 140 kg) and/or joint contractures - Skin lesions and/or pressure ulcers in areas where the support harness or LOPES II straps are to be fitted

Design outcomes

Primary

Measure	Time frame
- Quality of gait pattern in terms of symmetry in kinematics and mechanical work - Individual goals gait: > Efficiency: Mechanical work derived from COM displacement and movement of body segments. > Stability in Stance: knee and hip angles during single stance, step width and single stance symmetry > Foot clearance: peak hip, knee and foot angles during swing phase, minimal foot clearance during swing phase > Foot prepositioning: peak knee extension and ankle dorsiflexion angles in terminal swing > Step length: step length and step length symmetry	—

Measure

Time frame

- Quality of gait pattern in terms of symmetry in kinematics and mechanical work - Individual goals gait: > Efficiency: Mechanical work derived from COM displacement and movement of body segments. > Stability in Stance: knee and hip angles during single stance, step width and single stance symmetry > Foot clearance: peak hip, knee and foot angles during swing phase, minimal foot clearance during swing phase > Foot prepositioning: peak knee extension and ankle dorsiflexion angles in terminal swing > Step length: step length and step length symmetry

—

Secondary

Measure	Time frame
- Leg motor function - Walking ability - Patient’s experience about training in LOPES II	—

Contacts

Public ContactBertine Fleerkotte

Roessinghsbleekweg 33b

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)