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Investigating evidence of the benefits of dynamic joint orthoses for the redression of joint contractures in children and adolescents

Investigating evidence of the benefits of dynamic joint orthoses for the redression of joint contractures in children and adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00013608
Enrollment
40
Registered
2018-01-09
Start date
2018-06-18
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Joint malalignemts and joint contractures of the knee, hand, ankle and/or elbow

Interventions

Group 1: CDS orthoses for the treatment of the knee joint in extension: Individual treatment plan (daily, night, duration, intensity of the redression) for the CDS orthoses individually per patient ac

Sponsors

albrecht GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: - Children aged 5 to 18, male and female - contractures of the diseased joint in extension and / or flexion (symptom) - Joint deformities due to neuromuscular and surgical-orthopedic (with / without neurological components) indications - Patient should receive a CDS orthoses for therapy after clinical decision by the attending physician - Patient may reappear in the next 12 weeks - Parents of the patient understand the participation in the observational study and agree with the participation - joint contractures: - in cerebral palsy - After strokes or spinal cord injuries - in paralysis - After traumatic brain injury - After polytraumata - After surgery - After immobilization - After capsule ligament injuries - In rheumatoid arthritis - After burns - After infections - Torn muscle of the quadriceps - Haemophiliac joint - Fissure of the patellar tendon - wekaness of the quadriceps - fractures - For the prevention of renewed contractures e.g. after prolongation of tendons, or other indications in which an active stretching - or bowing of the joint is contraindicated

Exclusion criteria

Exclusion criteria: - Inadequate compliance or mental disorders - Non-consent of the parents - Participation in another clinical examination - Lack of readiness / possibility of parents to introduce the child to clinical follow-up - Implementation of a modified therapy program in the last 3 months or during of the observation period - Injuries or wounds in the areas where the orthoses are in contact - Clinically bony blockages - Osteoporosis with known or feared spontaneous fractures - Thrombophlebitis - Planned surgery on the affected joint - Lack of compliance on the part of the child

Design outcomes

Primary

MeasureTime frame
Elimination/reduction of contractures and/or improvement of the range of motion in the joints For this purpose, the range of motion of the joints will be quantified non-invasively using a goniometer. The neutral zero method is used. Measuring times are before the start of therapy and 6 and 12 weeks and 6 and 12 months after the start of therapy with the CDS splints.

Secondary

MeasureTime frame
- Reduction of pain (e.g. Wong-Baker Faces Pain Rating Scale, Peadiatric Pain Profile) - improved quality of life (e.g. Child Health Questionnaire, CPCHILD) - improved participation in daily life (e.g. PEMCY, Goal Attainment Scaling) - faster therapy success (e.g. Challenge Module) - Patient compliance to achieve therapy success (e.g. Goal Attainment Scaling) For this purpose, standardized scales and questionnaires are used, depending on the individual underlying disease and the predefined treatment goal. Assessment dates are before the start of therapy and 6 and 12 weeks and 6 and 12 months after initiation of therapy with the CDS orthoses. - satisfactory benefit / risk analysis Therapy success and side effects / adverse events are recorded. - Savings from continuous home therapy through shorter rehabilitation and reduced home care. For this purpose, the achieved therapeutic goals should first be compared with the expected therapeutic goals. This will only give a rough guideline for further investigations. - Formulate recommendations for the domestic sector. For this purpose, the results of all patients should be summarized in order to be able to judge better the length, frequency and time of day for use.

Countries

Germany

Contacts

Public ContactAngela Kaindl

Sozialpädriatisches Zentrum/SPZ Charité – Universitätsmedizin Berlin

petra.boettcher@charite.de+49 30 450 566 002

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026