The effect of GRAIL training on functional walking capacity and social participation in patients with incomplete spinal cord injury.

The effect of GRAIL training on functional walking capacity and social participation in patients with incomplete spinal cord injury. - Effect of GRAIL training in incomplete spinal cord injury.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48297

Enrollment

Registered

2019-08-05

Start date

2019-10-22

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

incomplete spinal cord injury partial paralysis

Interventions

The GRAIL intervention consist of twelve one-hour training sessions spread over a six-week period. During the GRAIL intervention the focus is on training gait adaptability on a treadmill using a vir

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria - SCI classification (American Spinal Injury Association Impairment Scale (AIS) C or D)) - At least 6 months post injury-onset to ensure a stable neurological condition - Able to walk at least 10m with or without a walking aid and/or braces - Walking speed at inclusion between 0 3 and 1 0 m/s (measured with the 10MWT) - A rehabilitation goal on improving (functional) walking capacity - Age >18 years - Willingness and ability to cancel/postpone other interventions or treatments aimed at improving functional balance capacity or participation during the study duration

Exclusion criteria

Exclusion criteria: The main exclusion criteria are - Other neurological or lower limb impairments in addition to the iSCI - Walking or balance problems prior to the iSCI - Expected life events during the study period that influence the activity level of the patient (such as retirement, parenthood, a new job or an operation) - Within the first 6 months after a previous GRAIL trajectory - Scheduled Botulinum Toxin (Botox) injections during the intervention period. - Insufficient understanding or mastery of the Dutch language to understand training and measurement instructions

Design outcomes

Primary

Measure	Time frame
1. Walking speed measured with the 2 minutes walking test (2MWT).	—

Secondary

Measure	Time frame
2. Functional walking ability measured with the spinal cord injury - functional ambulation profile (SCI-FAP) 3. Participation measured with the Utrecht scale for evaluation of rehabilitation-participation (USER-P). 4. Two rehabilitation goals, one on the activity level and one on participation level of the ICF, assessed with the Goal Attainment Scaling (GAS) 5. Walking speed measured with the 2 minute walking test (2MWT) during self-paced treadmill walking on the GRAIL. 6. Balance confidence measured with the activities-specific balance confidence (ABC) scale 7. Patients* experience on the different interventions will be captured with a customized questionnaire.	—

Measure

Time frame

2. Functional walking ability measured with the spinal cord injury - functional ambulation profile (SCI-FAP) 3. Participation measured with the Utrecht scale for evaluation of rehabilitation-participation (USER-P). 4. Two rehabilitation goals, one on the activity level and one on participation level of the ICF, assessed with the Goal Attainment Scaling (GAS) 5. Walking speed measured with the 2 minute walking test (2MWT) during self-paced treadmill walking on the GRAIL. 6. Balance confidence measured with the activities-specific balance confidence (ABC) scale 7. Patients* experience on the different interventions will be captured with a customized questionnaire.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)