|- candidate number||27075|
|- NTR Number||NTR6295|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-apr-2017|
|- Secondary IDs||NL56888.018.16 ABR nummer|
|- Public Title||ReValidate! trial - A Serious Game for Rehabilitation after Distal Radius Fractures|
|- Scientific Title||ReValidate! trial - A Serious Game for Rehabilitation after Distal Radius Fractures
|- hypothesis||A serious game for wrist rehabilitation will be more effective at improving functional outcomes, pain scores and range of motion, compared to standard treatment regimens either or not including physiotherapy.|
|- Healt Condition(s) or Problem(s) studied||Distal radius fracture|
|- Inclusion criteria||1. Any type of closed distal radius fracture with no injury to the skin of the affected limb.|
2. Good position after reposition or operative fixation, defined by <10 degrees of inclination in any direction, <5 mm shortening of the radius compared to the ulna, <2 mm disposition of intra-articular fragments.
3. Fracture primarily treated with conservative (cast) immobilization or operative fixation (ORIF).
4. Fracture considered to be consolidated by treating physician (trauma- or orthopedic surgeon or surgical resident in training)
5. Possible to start rehabilitation exercises within 5 days after cast removal or operative fixation, as judged by treating physician (trauma- or orthopedic surgeon or surgical resident in training)
6. Age ≥ 18 years.
7. Written informed consent.
|- Exclusion criteria||1. Polytraumatized patients (Injury Severity Score ≥16).|
2. Bilateral wrist fractures or other injuries to the affected limb.
3. Patients with other disease or injury affecting use of wrist or range of motion (including Parkinsonís disease, having had a cerebral vascular accident, amyotrophic lateral sclerosis, neuropathy of any kind)
4. Previous fractures or any condition affecting the injured wrist with residual pain, loss of function or range of motion.
5. Any medical contra-indication to start rehabilitation within 5 days after operation or cast removal, as decided by the treating specialist.
6. Insufficient proficiency of Dutch or English in speech and written language, or inability to complete the Dutch questionnaires.
7. Not in the possession of, or able to obtain for the duration of our study, a smartphone compatible with the serious game.
8. Visual impairment preventing proper use of the smartphone-based game.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2017|
|- planned closingdate||30-jun-2018|
|- Target number of participants||92|
|- Interventions||We investigate the effect of a serious game for wrist rehabilitation, played on a smartphone or tablet and controlled using a motion sensor. The effect on functional outcome is compared to the current standard rehabilitation protocol after distal radius fractures, consisting of instructions for home-exercises with or without a physiotherapy referral.|
|- Primary outcome||PRWE|
|- Secondary outcome||- Active and passive range of motion in the wrist.|
- Grip strength.
- Pain score (VAS).
- Self-reported treatment adherence.
|- Timepoints||2, 6 and 12 weeks after start rehabilitation.|
|- Trial web site||www.revalidate.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD MSc H.A.W. Meijer|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. M.P. Schijven|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Amsterdam, CZ Fonds, Growing Games|
|- Brief summary||Rationale:|
Immediately after distal radius fractures are considered to be consolidated, exercises are prescribed in order to preserve flexibility in the radiocarpal joint (following direct osteosynthesis) or to regain lost range of motion and strength (after conservative cast treatment). There is, however, contradicting evidence on the effectiveness of current treatments, and adherence to existing therapy regimens is low.
To determine the effectiveness of the use of a serious game as a therapeutic tool for wrist rehabilitation after treatment of a closed distal radius fracture, in comparison to standard therapy. The effects on reported functional outcomes of rehabilitation treatment are measured using a standardized questionnaire (the Patient-Rated Wrist Evaluation), by measuring the range of motion in the radiocarpal joint at set time-points in the clinic and by recording pain scores using the Visual Analogue Scale. It is hypothesized that the serious game will be more effective than standard treatment regimens at improving functional outcomes, observed range of motion and reported pain score after six weeks of treatment.
Multicenter randomized controlled clinical trial.
Consented patients, ages 18 years and over with any type of closed distal radius fracture, treated conservatively or operatively, with no other concomitant traumatic injuries are eligible for inclusion in the trial.
Patients are randomized either to receive rehabilitation using the serious game (intervention group) or to standard treatment (control group).
The primary endpoint is the change in functional outcome between baseline and follow-up as measured by the self-reported Patient-Rated Wrist Evaluation (PRWE) scores. Secondary outcomes are the active and passive range of motion, grip strength, pain, and self-reported treatment adherence.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The serious game will be downloaded and installed on the smartphones of patients in the intervention group. Patients in the intervention group will receive a motion sensor to control the game on loan from the hospital. They will receive training on how to use the game and the sensor optimally. Patients in the control group will receive standardized instructions and a referral for physiotherapy.
Three follow-up meetings at the outpatient clinic will be scheduled for both intervention and control group, which are in concordance with the regular follow-up visits after operatively treated distal radius fractures. For conservatively, by means of a cast, treated patients, this means they will have two extra follow-up meetings compared to the standard treatment protocol.
The risks for the intervention group are considered to be low, since patients will be practicing the exact same motions as they would be when supervised by a physiotherapist, as the game is calibrated and can only be played when executing these motions correctly.
|- Main changes (audit trail)|
|- RECORD||12-apr-2017 - 17-mei-2017|