An interventional study of Home-based protocol in specific tasks and Upper-limb splint in Hemiplegia and Hemiparesis and Cerebral Palsy Infantile, sponsored by Universidad San Jorge. Completed at 2 sites in Spain. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-07-17.
Sponsored by Universidad San Jorge · Not applicable, Interventional, and Treatment
Among 16 studies in Hemiplegia with a site in Spain — 2 open to participants now, 2 under way, none of them phase 3. Hemiplegia · Spain.
Among the 16 studies in Hemiplegia with a site in Spain, this one is the 7th largest by enrollment, is one of 2 that started in 2017, is one of 15 with no phase, and was the 3rd registered.
446 studies on the registry are indexed under Hemiplegia; 90 are open to participants now.
This study's enrollment of 33 is close to the median of 34 across 370 interventional studies indexed under Hemiplegia.
Browse Hemiplegia studies →2 of the 16 studies in Hemiplegia with a site in Spain are open now, in 3 countries. Each count lists the studies.
Of the 57 Hemiplegia studies recruiting now, 16 (28%) set no upper age limit and 29 (51%) stop at 75 or younger; 8 take children under 18; 7 take healthy volunteers.
This study: 5 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2017.
Median enrollment 25 across the 16 interventional studies. Of the 11 that completed or were terminated, 0 (0%) have results posted.
1 of 16 have an industry lead sponsor. The 10 most frequent:
Universidad San Jorge is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Universidad San Jorge has 1 study filed under Hemiplegia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Hemiplegia with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
The main objective:
To determine the effectiveness of a treatment that combines the application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy versus a home-based program of specific tasks in improving structure and function, activity and participation.
Hypothesis:
The application of a functional upper limb orthosis together with a home-based program of specific tasks in children with unilateral cerebral palsy results in a greater improvement in structure and function, activity and participation compared to the implementation of a home-based specific task program.
Randomized clinical trial with blinding of the evaluator and the person analyzing the data.
A home-based protocol of specific tasks will be performed in both groups and one of the groups will also receive a treatment with upper limb splinting. The assessment will be made by a single evaluator with 10 years of experience in the treatment of children with motor disabilities.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Upper-limb splint and home-based protocol in specific tasks
Device: Home-based protocol in specific tasks · Device: Upper-limb splint
Home-based protocol in specific tasks
Device: Home-based protocol in specific tasks
The home-based protocol in specific tasks will be an individualized protocol designed for the child according to the results of the baseline assessment and will require active participation. It is a program that is integrated into the daily routines of the child. A study investigator will tell the family the procedure to follow.
In the case that treatment with splint is also received, a researcher of this study will take measurements of the hand and will provide the appropriate splint. The intensity of the application will be 5 days a week from monday to friday, for 6 hours a day, for a period of 6 weeks.
Primary Outcome_Change from baseline Assisting Hand Assessment measure. Measurement of bimanual performance in pre-established tasks
Activity measurement: Assisting Hand Assessment. Measurement of bimanual performance in pre-established tasks. It quantifies the effectiveness with which the child uses his affected hand in bimanual activities.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Primary Outcome_2. Change from baseline Children's Hand-use Experience Questionnaire measure. Measurement of bimanual performance in activities of daily living.
Participation and activity measurement: Children's Hand-use Experience Questionnaire. The objective of the questionnaire is to measure bimanual performance in activities of daily living.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_Change from baseline Box and Blocks Test measure. Measurement of unilateral gross manual dexterity.
Activity measurement: Box and Blocks Test assesses unilateral gross manual dexterity.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_2. Change from baseline Jebsen Hand Function Test measure. Measurement of a broad range of uni-manual hand functions required for activities of daily living.
Participation measurement: Jebsen Hand Function Test. The objective of this test is to assess a broad range of uni-manual hand functions required for activities of daily living.7 activities performed with the affected hand and healthy hand separately.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_3. Change from baseline House Thumb in Palm Deformity Classification. Classify the deformity level of thumb.
Structure and function measurement: House Thumb in Palm Deformity Classification. This tool classify the deformity levels taking into account the structure of the thumb.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_4. Change from baseline Neurological Hand Deformity Classification. This tool classify the deformity levels of wrist and fingers.
Structure and function measurement: Neurological Hand Deformity Classification. This tools classify the deformity levels taking into account the wrist, fingers.
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Secondary Outcome_5. Change from baseline Grip and Pinch Strength measure. Measurement of pinch, wrist and foream strength.
Structure and function measurement: Grip and Pinch Strength. One will be used to Assess the grip of the thumb (Pinch Gauge Dynamometer) and another to assess the strength of the wrist and forearm (Hand and Wrist Dynamometer).
Time frame: Pre-intervention; Post-intervention (6 weeks after); Follow up (8 weeks after the intervention).
Plan to share: No
Ran from Sep 2017 to primary completion in Feb 2019, 17 months.
Of 223 non-industry interventional studies with no phase under Hemiplegia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 17 months is above that.
Counting every sponsor, half of 228 studies reached it within 12 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Universidad San Jorge