Effect of GRAIL training in incomplete spinal cord injury

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22779

Enrollment

Registered

2019-08-13

Start date

2019-10-20

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

People with a chronic (&gt

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 virtu

Exercise therapy

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Incomplete dwarslaesie (American Spinal Injury Association Impairment Scale (AIS) C of D) Minimaal 6 maanden na het begin van het letsel om een stabiele neurologische toestand te waarborgen - In staat om minimaal 10 meter te lopen met of zonder loophulpmiddel - Loop snelheid bij inclusie tussen 0.3 en 1.0 m/s (gemeten met de 10MWT) - Een revalidatiedoel gericht op het verbeteren van (functionele) loopcapaciteit - Leeftijd =18 jaar - Bereidheid en vermogen om andere interventies of behandelingen gericht op het verbeteren van functionele balanscapaciteit of participatie gedurende de studieperiode te annuleren/uitstellen

Exclusion criteria

Exclusion criteria: - Andere neurologische of beperking aan de onderste extremiteiten naast de dwarslaesie - Loop- of balansproblemen voorafgaand aan de dwarslaesie - Verwachte levensgebeurtenissen tijdens de onderzoeksperiode die invloed hebben op het activiteitsniveau van de deelnemer (zoals pensionering, ouderschap, een nieuwe baan of een operatie) - Binnen de eerste 6 maanden na een eerder GRAIL-traject - Geplande botuline toxine (Botox) injecties tijdens de interventieperiode - Onvoldoende begrip van of beheersing van de Nederlandse taal om trainings- en meetinstructies te begrijpen

Design outcomes

Primary

Measure	Time frame
The primary outcome parameter is walking speed measured with the 2MWT during overground walking. This outcome will be assessed five times.	—

Secondary

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

Measure

Time frame

Secondary study parameters are: - Functional walking ability measured with the spinal cord injury – functional ambulation profile (SCI-FAP) - Participation measured with the Utrecht scale for evaluation of rehabilitation-participation (USER-P). - Two rehabilitation goals, one on the activity level and one on participation level of the ICF, assessed with the Goal Attainment Scaling (GAS) - Walking speed measured with the 2 minute walking test (2MWT) during self-paced treadmill walking on the GRAIL. - Balance confidence measured with the activities-specific balance confidence (ABC) scale - Patients’ experience on the different interventions will be captured with a customized questionnaire. These outcome measures will be assessed three times.

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Contacts

Public ContactEline Zwijgers

Sint Maartenskliniek & Radboudumc

e.zwijgers@maartenskliniek.nl+31243659499

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)