An interventional study of Virtual Reality in Muscle Spasticity, sponsored by Gillette Children's Specialty Healthcare. Completed at 1 site in United States. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Gillette Children's Specialty Healthcare · Not applicable, Interventional, and Supportive care
Among 165 studies in Muscle Spasticity with a site in United States — 34 open to participants now, 44 under way, none of them phase 3. Muscle Spasticity · United States.
Among the 165 studies in Muscle Spasticity with a site in United States, this one is the 49th largest by enrollment of the 130 interventional ones that give a count, is one of 11 that started in 2018, is one of 59 with no phase, and was the 99th registered.
621 studies on the registry are indexed under Muscle Spasticity; 127 are open to participants now.
Browse Muscle Spasticity studies →34 of the 165 studies in Muscle Spasticity with a site in United States are open now. Recruiting first, the newest first:
Kessler Foundation · Sites in United States
Ages 22+
Kessler Foundation · Sites in United States
Ages 18+
Alberto Esquenazi · Sites in United States
Ages 18–80
Martin Piazza · Sites in United States
Ages 3–14
Yale University · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 88 Muscle Spasticity studies recruiting now, 29 (33%) set no upper age limit and 47 (53%) stop at 75 or younger; 34 take children under 18; 11 take healthy volunteers.
This study: 4 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
165 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 29 · Phase 3 25 · Phase 4 9
First in 1997; this study’s year is marked. 11 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 49 is above the median of 36 across 472 interventional studies indexed under Muscle Spasticity.
Median enrollment 31 across the 130 interventional studies, 55 across the 34 observational. Of the 108 that completed or were terminated, 44 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
49 of 165 have an industry lead sponsor. The 10 most frequent:
Gillette Children's Specialty Healthcare is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Gillette Children's Specialty Healthcare has 1 study filed under Muscle Spasticity — fewer than ten, so there is no comparison to draw.
17 of the studies in Muscle Spasticity with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07516067Martin PiazzaSpinal Cord Stimulation for Children With Cerebral Palsy | 2026-11 |
| NCT07792616University of Mississippi Medical CenterElectrical Neuromodulation for Modifying Spinal Network Involved in Spasticity | 2026-12-31 |
| NCT05094362Medical University of South CarolinaOperant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning | 2026-12-31 |
| NCT06070233Ohio State UniversityRadiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy | 2026-12-31 |
| NCT06341023University of Illinois at ChicagoFunctional Balance Intervention in Multiple Sclerosis | 2027-01-09 |
Add all 17 to your calendar (.ics) → With an account.
Among the 165 studies in Muscle Spasticity with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Measure pain and anxiety during a putative painful medical procedure (i.e., botulinum toxin injections) when Virtual Reality is employed compared to standard of care only using a Randomized Controlled Trial study design.
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:
The application of VR during the putative painful treatment (botulinum toxin injections) will provide a) active and engaging distraction during the procedure, and will b) block the view and auditory noise related to the procedure.
Device: Virtual Reality
Patients will receive the standard of care for the putative painful treatment (botulinum toxin injections).
Participants will have the opportunity to choose a game or relaxation experience to utilize during a botulinum toxin injection to distract from pain and anxiety during one visit. Virtual Reality will not be available during the other visit. AppliedVR has a number of games and relaxation experiences available for participants to chose from.
Also known as: AppliedVR
The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections.
The Faces Pain Scale - Revised (FPS-R) will be used to assess pain intensity before, during, and after the treatment session. The FPS-R is a self-report measure of pain intensity developed for children. This scale shows a serious of six faces depicting increasing intensity of pain expression. The FPS-R instructions orient the child to the series of faces and then ask the child to point to the face that shows how much they hurt right now. Each face corresponds to a numerical rating between 0 and 10 (0, 2, 4, 6, 8, and 10). This rating scale corresponds to the widely accepted 0-to-10 metric for pain. The "0" equals no pain and the "10" equals very much pain. The score is reported as a total score.
Time frame: 2 days
A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR.
A visual analogue scale (VAS) will be used to quantify multiple aspects of the treatment experience expected to be impacted by the use of VR. The VAS will be a 10 cm 0-100 scale and will assess the following: patient anxiety before, during and after the procedure; parent/caregiver anxiety before, during, and after the procedure; proportion of the treatment time spent thinking about pain; worst pain during treatment; satisfaction with pain management; and nausea during treatment. This will be done at both visits (VR and no-VR).
Time frame: 2 days
Information collected from the medical record (e.g., medication use during procedure).
Following the signing of a HIPPA release, the medical record will be accessed to obtain such information as: patient diagnosis, date of birth, ethnicity, number of botulinum toxin injections, muscles injected, patient weight, height, and temperature, heart rate, blood pressure and oxygen saturation during treatment, clinical description of the context of VR use; provider description of whether VR enhanced clinical care; reduction or avoidance of medication due to VR; total amounts of medications given (e.g., valium, nitrous oxide, opioids; mg/kg); and notation of patient side effects from VR. This will be done at both visits (VR and no-VR).
Time frame: 2 days
The Pain Opinion Questionnaire (POQ)
The Pain Opinion Questionnaire (POQ) requires caregivers to respond to 5 questions in 3 separate sections regarding children with mild, moderate, and severe/profound intellectual and developmental disabilities. A description of the abilities and limitations of a typical individual with each level of impairment is provided in each section. The questions address 5 facets of pain: (a) the ability of the children to sense painful stimuli (Sensation), (b) how upset or distressed the children feel while in pain (Emotional Reaction), (c) how strongly the children react behaviorally to pain (Behavioral Reaction), (d) how much the children communicate their pain to others (Communication), and (e) how much pain the children suffer (Frequency). We are modifying the scale to require parents or caregivers to estimate whether they believe their child (not a hypothetical child) would experience that aspect of pain the "same as", "less than", or "more than" children without impairment.
Time frame: 2 days
The Dalhousie Pain Interview (DPI)
The Dalhousie Pain Interview (DPI) will provide a measure of pain experience in the previous week, including pain frequency (number of pain episodes), intensity (rated 0-10) and duration (number of seconds or minutes in pain). The measure consists of 10 items and was designed explicitly as an interview/survey script.
Time frame: 2 days
The Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) will provide a measure of pain interference in the previous week (i.e., the degree to which ongoing pain interferes with daily living). The BPI is a 10-item, 11-point scale (0 = does not interfere, 10 = completely interferes). The items include general activity, mood, mobility, normal work, relationships with other people, sleep, enjoyment of life, self-care, recreational activities, and social activities. Total score (sum of all 12 items combined; range 0-120) and average score (average item score; range 0-10) will be assessed.
Time frame: 2 days
Plan to share: No
Ran from Sep 2018 to primary completion in May 2023, 55 months.
Of 226 non-industry interventional studies with no phase under Muscle Spasticity, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's 55 months is above that.
Counting every sponsor, half of 234 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: primary completion Dec 2023 → May 2023 and completion Dec 2024 → May 2023.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gillette Children's Specialty Healthcare