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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Enhancing Recovery of Arm Movement in Stroke Patients

NCT02725853

Stroke Arm Paresis

COMPLETED NA

Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke

NCT04188769

Deep Pressure Muscle Activity General Relaxation +2 more

WITHDRAWN NA

The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position in Chronic Stroke Patients

NCT03112616

Hemiplegia Stroke

COMPLETED

The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population

NCT05315726

Post-stroke Patient in Acute, Sub-acute Phase or Chronic

RECRUITING NA

BCI-controlled NMES in Subacute Stroke

NCT03379532

Stroke

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DOC - real

Spastic patients with disorders of consciousness receiving the real soft splint

Group Type ACTIVE_COMPARATOR

Real soft splint (6 cm)

Intervention Type DEVICE

DOC - placebo

Spastic patients with disorders of consciousness receiving the placebo soft splint

Group Type PLACEBO_COMPARATOR

Placebo soft splint (1 cm)

Intervention Type DEVICE

Stroke - real

Spastic patients stroke receiving the real soft splint

Group Type ACTIVE_COMPARATOR

Real soft splint (6 cm)

Intervention Type DEVICE

Stroke - placebo

Spastic patients stroke receiving the placebo soft splint

Group Type PLACEBO_COMPARATOR

Placebo soft splint (1 cm)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Real soft splint (6 cm)

Intervention Type DEVICE

Placebo soft splint (1 cm)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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) prior to the accident
* Botox injection on the upper limbs in the 6 months preceding the inclusion

* 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

Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No