Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03442660
Other study ID # F-FR-52120-232
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2018
Est. completion date August 9, 2019

Study information

Verified date September 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to describe the psychometric properties (validity, reliability and responsiveness) of the SQOL-6D instrument in the context of routine clinical treatment of upper limb spasticity.


Description:

The study qualifies as interventional not because of the use of an investigational product, but because the imposed specific data collection procedures include multiple questionnaire assessments and one on-site visit not necessarily part of routine clinical practice.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date August 9, 2019
Est. primary completion date August 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Currently resident in the UK

- Subjects with a diagnosis of ULS

- Receiving a treatment at the enrolment visit, as part of their routine clinical management, aiming at reducing spasticity

- Sufficient grasp of English and cognitive ability to be able to understand the SQOL-6D questions, give informed consent and complete the protocol requirements as judged by the investigator

Exclusion Criteria:

- The subject has already been included in the study

- The subject, in the opinion of the investigator, would be unable to understand the questionnaire or to comply with the requirements of the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional diagnostic or treatment procedures will be required. Subjects will be asked to complete electronic (or on paper when it's not possible to use electronic version) questionnaires.

Locations

Country Name City State
United Kingdom Hull and East Yorkshire NHS Trust, Castle Hill Hospital Cottingham
United Kingdom Mid Yorkshire Hospitals NHS Trust, Dewsbury Hospital Dewsbury
United Kingdom London North West NHS Healthcare Trust - Regional Hyper-acute Rehabilitation Unit Harrow
United Kingdom University Hospitals of Leicester NHS Trust, Neurology Department, Leicester General Hospital Leicester
United Kingdom Northumberland Tyne and Wear NHS trust, Walkergate Park Neuro-Rehabilitation Newcastle
United Kingdom Staffordshire and Stoke-on-Trent Partnership NHS Trust, North Staffordshire Rehabilitation Centre, Haywood Hospital Stoke-on-Trent
United Kingdom City Hospitals Sunderland NHS Foundation Trust Research and Innovation Education Centre Sunderland
United Kingdom South Warwickshire NHS Foundation Trust, Central England Rehabilitation Unit Leamington Spa Hospital Warwick

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validation of SQOL-6D in upper limb spasticity Validity - Reliability - Responsiveness Change from baseline (day 1) to 8 weeks +/-2 weeks (follow up visit)
Secondary EQ-5D-5L (EuroQoL 5 Dimensions, 5 Levels) A summary index score will be calculated from responses given to the 5 domain items, measuring overall health on a scale 0 to 1 using United Kingdom (UK) value sets. Day 1 and then 8 weeks +/-2
Secondary Neurological Impairment Scale adapted for ULS (ULS-NIS) Records functional impairment on a four-point scale (rated 0-3) across seven domains, including: motor impairment in the affected upper limb, sensation affected in the affected upper limb, communication, cognitive function, cortical function, emotional/behaviour and mobility of joints, as measured by soft tissue shortening (an assessment used for the evaluation of the deterioration in range of movement due to spasticity by percentage loss of range). Day 1
Secondary Modified Ashworth Scale (MAS) Six-point scale (with available scores of 0, 1, 1+, 2, 3 and 4) evaluates muscle tone by reporting changes in this during muscle flexion or extension, depending on the (resistance in) joint mobility being assessed (shoulder, elbow, wrist or finger). Day 1 and then 8 weeks +/-2
Secondary Gaseous (Goal Attainment Scaling Evaluation of Outcome for Upper-Limb Spasticity) Goal attainment will be recorded on a five point numerical scale (range -2 to +2) and goal scores combined to give an aggregated T score. Day 1 and then 8 weeks +/-2
Secondary ArmA (Arm Activity Measure) Scores ArmA is a patient-reported outcomes questionnaire recording the difficulty in caring for, and completing tasks and activities with the affected arm. The ArmA contains a total of 29 items in four subscales. Difficulty for each item is assessed on a five-point scale (range 0 to 4). Day 1 and then 8 weeks +/-2
Secondary Global assessment of benefit The Global Assessment of Benefit scale will be completed by the subject. Responses options will be: Much worse (-2)/Worse (-1)/Same (0)/Some benefit (+1)/Great benefit (+2). 8 weeks +/-2
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT03908580 - MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity Phase 4
Not yet recruiting NCT04550793 - Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
Recruiting NCT05432999 - Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury N/A
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
Active, not recruiting NCT05562453 - Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain N/A
Recruiting NCT06214975 - EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2) N/A
Recruiting NCT05464160 - Focal Muscular Vibration in Patients With Severe Acquired Brain Injury N/A
Completed NCT04130295 - Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury N/A
Recruiting NCT06070233 - Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy N/A
Completed NCT03747900 - Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity N/A
Completed NCT03307135 - Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity N/A
Recruiting NCT05070780 - Neurophysiological Evaluation of Muscle Tone
Recruiting NCT04620707 - RGS@Home: Personalized 24/7 Home Care Post-stroke N/A
Recruiting NCT06109129 - Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy N/A
Enrolling by invitation NCT05598736 - Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain N/A
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Active, not recruiting NCT05626790 - Effects of PNF and Static Stretching on Architecture and Viscoelastic Properties of Hemiplegic Elbow N/A
Recruiting NCT04904016 - Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity N/A
Withdrawn NCT05887479 - The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity Phase 4