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ReValidate! The effect of a serious game compared to standard therapy for rehabilitation after distal radius fractures

ReValidate! The effect of a serious game compared to standard therapy for rehabilitation after distal radius fractures - ReValidate!-trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53062
Enrollment
92
Registered
2016-10-17
Start date
2017-05-24
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal radius fracture wrist fracture

Interventions

Patients are randomized either to receive rehabilitation using the serious game (intervention group) or to standard treatment (control group).

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 = 18 years. 7. Written informed consent.

Exclusion criteria

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 Parkinson*s 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 our serious game. 8. Visual impairment preventing proper use of the smartphone-based game.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcomes are the active and passive range of motion, grip strength, pain, and self-reported treatment adherence.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)