Back to results

Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness

Primary Purpose

Brain Injuries, Disorder of Consciousness, Stroke

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Real soft splint (6 cm)

Placebo soft splint (1 cm)

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (DOC):

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

Exclusion Criteria:

Bone fracture/lesion at the upper limbs
Serious neurological disorder (MMSE > 24) prior to the accident
Botox injection on the upper limbs in the 6 months preceding the inclusion

Inclusion Criteria (stroke):

Central nervous system injury responsible for the spasticity
Ashworth score > 1 for at least one upper limb joint

Exclusion Criteria:

Bone fracture/lesion at the upper limbs
Serious neurological disorder (MMSE > 24)
Botox injection on the upper limbs in the 6 months preceding the inclusion

Sites / Locations

Centre Hospitalier Neurologique William Lennox

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

DOC - real

DOC - placebo

Stroke - real

Stroke - placebo

Arm Description

Spastic patients with disorders of consciousness receiving the real soft splint

Spastic patients with disorders of consciousness receiving the placebo soft splint

Spastic patients stroke receiving the real soft splint

Spastic patients stroke receiving the placebo soft splint

Outcomes

Primary Outcome Measures

Change in the Modified Ashworth Scale

Spasticity assessment

Change in the Modified Tardieu Scale

Spasticity assessment

Change in the Nociception Coma Scale-Revised

Pain assessment

Change in the Visual Analogue Scale

Pain assessment

Change in the Palm-finger distance

Range of motion assessment

Secondary Outcome Measures

Change in the Coma Recovery Scale-Revised

Consciousness assessment

Full Information

NCT ID

NCT03008486

First Posted

December 26, 2016

Last Updated

September 24, 2019

Sponsor

Géraldine Martens

Collaborators

Centre Hospitalier Universitaire UCLouvain Namur

1. Study Identification

Unique Protocol Identification Number

NCT03008486

Brief Title

Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness

Official Title

Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

January 2017 (undefined)

Primary Completion Date

January 2019 (Actual)

Study Completion Date

June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Géraldine Martens

Collaborators

Centre Hospitalier Universitaire UCLouvain Namur

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major muscular troubles such as spasticity. This spasticity may induce pain, loss in range of motion and permanent joint deformities. The aim of this study is to investigate the effects of soft splinting on the hand spasticity in both patients with stroke and patients with disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50 with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1 cm diameter). Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain and consciousness assessments will be performed at baseline (week 0), after 1 week of treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later (week 6) and three months later (week 12).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injuries, Disorder of Consciousness, Stroke, Spasticity as Sequela of Stroke, Contracture, Hypertonic Disorder, Central Nervous System Diseases, Pathologic Processes, Craniocerebral Trauma, Trauma, Nervous System, Neurocognitive Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DOC - real

Arm Type

Active Comparator

Arm Description

Spastic patients with disorders of consciousness receiving the real soft splint

Arm Title

DOC - placebo

Arm Type

Placebo Comparator

Arm Description

Spastic patients with disorders of consciousness receiving the placebo soft splint

Arm Title

Stroke - real

Arm Type

Active Comparator

Arm Description

Spastic patients stroke receiving the real soft splint

Arm Title

Stroke - placebo

Arm Type

Placebo Comparator

Arm Description

Spastic patients stroke receiving the placebo soft splint

Intervention Type

Device

Intervention Name(s)

Real soft splint (6 cm)

Intervention Type

Device

Intervention Name(s)

Placebo soft splint (1 cm)

Primary Outcome Measure Information:

Title

Change in the Modified Ashworth Scale

Description

Spasticity assessment

Time Frame

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

Title

Change in the Modified Tardieu Scale

Description

Spasticity assessment

Time Frame

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

Title

Change in the Nociception Coma Scale-Revised

Description

Pain assessment

Time Frame

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

Title

Change in the Visual Analogue Scale

Description

Pain assessment

Time Frame

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

Title

Change in the Palm-finger distance

Description

Range of motion assessment

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in the Coma Recovery Scale-Revised

Description

Consciousness assessment

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (DOC): 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 Exclusion Criteria: Bone fracture/lesion at the upper limbs Serious neurological disorder (MMSE > 24) prior to the accident Botox injection on the upper limbs in the 6 months preceding the inclusion Inclusion Criteria (stroke): Central nervous system injury responsible for the spasticity Ashworth score > 1 for at least one upper limb joint Exclusion Criteria: Bone fracture/lesion at the upper limbs Serious neurological disorder (MMSE > 24) Botox injection on the upper limbs in the 6 months preceding the inclusion

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Lejeune

Organizational Affiliation

Centre Hospitalier Neurologique William Lennox

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Neurologique William Lennox

City

Ottignies

State/Province

Brabant Wallon

ZIP/Postal Code

1340

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness

We'll reach out to this number within 24 hrs