NCT03008486

Brief Summary

The purpose of this study is to assess the effects on upper limb spasticity of soft splints worn during three weeks three hours a day by patients with stroke or disorders of consciousness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

December 26, 2016

Last Update Submit

September 24, 2019

Conditions

Brain InjuriesDisorder of ConsciousnessStrokeSpasticity as Sequela of StrokeContractureHypertonic DisorderCentral Nervous System DiseasesPathologic ProcessesCraniocerebral TraumaTrauma, Nervous SystemNeurocognitive Disorders

Outcome Measures

Primary Outcomes (5)

  • Change in the Modified Ashworth Scale

    Spasticity assessment

    Week 0, 1, 3, 4, 6, 12

  • Change in the Modified Tardieu Scale

    Spasticity assessment

    Week 0, 1, 3, 4, 6, 12

  • Change in the Nociception Coma Scale-Revised

    Pain assessment

    Week 0, 1, 3, 4, 6, 12

  • Change in the Visual Analogue Scale

    Pain assessment

    Week 0, 1, 3, 4, 6, 12

  • Change in the Palm-finger distance

    Range of motion assessment

    Week 0, 1, 3, 4, 6, 12

Secondary Outcomes (1)

  • Change in the Coma Recovery Scale-Revised

    Week 0, 1, 3, 4, 6, 12

Study Arms (4)

DOC - real

ACTIVE COMPARATOR

Spastic patients with disorders of consciousness receiving the real soft splint

Device: Real soft splint (6 cm)

DOC - placebo

PLACEBO COMPARATOR

Spastic patients with disorders of consciousness receiving the placebo soft splint

Device: Placebo soft splint (1 cm)

Stroke - real

ACTIVE COMPARATOR

Spastic patients stroke receiving the real soft splint

Device: Real soft splint (6 cm)

Stroke - placebo

PLACEBO COMPARATOR

Spastic patients stroke receiving the placebo soft splint

Device: Placebo soft splint (1 cm)

Interventions

Real soft splint (6 cm)DEVICE
DOC - realStroke - real
Placebo soft splint (1 cm)DEVICE
DOC - placeboStroke - placebo

Eligibility Criteria

Age14 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Altered state of consciousness according to international criteria since more than three months
  • Stable condition
  • Ashworth score \> 1 for at least one upper limb joint

You may not qualify if:

  • Bone fracture/lesion at the upper limbs
  • Serious neurological disorder (MMSE \> 24) prior to the accident
  • Central nervous system injury responsible for the spasticity
  • Ashworth score \> 1 for at least one upper limb joint
  • Bone fracture/lesion at the upper limbs
  • Serious neurological disorder (MMSE \> 24)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Neurologique William Lennox

Ottignies, Brabant Wallon, 1340, Belgium

Location

MeSH Terms

Conditions

Brain InjuriesConsciousness DisordersStrokeContractureCentral Nervous System DiseasesPathologic ProcessesCraniocerebral TraumaTrauma, Nervous SystemNeurocognitive Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesNervous System DiseasesWounds and InjuriesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesJoint DiseasesMusculoskeletal DiseasesMuscular Diseases

Study Officials

  • Nicolas Lejeune

    Centre Hospitalier Neurologique William Lennox

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

December 26, 2016

First Posted

January 2, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

June 1, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)