Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02073513
Other study ID # LUT 09/24-47
Secondary ID
Status Completed
Phase N/A
First received December 12, 2013
Last updated February 25, 2014
Start date November 2009
Est. completion date September 2010

Study information

Verified date February 2014
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.

OBJECTÄ°VES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on hand function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure hand function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.


Description:

BACKROUNDS: Thumb in palm deformity restricts hand function by prevent somatosensory input in the children with cerebral palsy who have spasticity in their hands.

OBJECTÄ°VES: To investigate the effects of thenar palmar kinesiotape application with and without pressure on upper extremity function in children with cerebral palsy. METHOD: 45 children were randomly allocated to one of the thenar taping groups either with or without pressure or to the control group. Nine hole peg test and nine parts puzzle test were used to measure upper extremity function. The two study groups were evaluated initially, with taping 20 minutes later and 20 minutes after taping was removed.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 14 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of Cerebral Palsy

- Stable clinical status

- Hand and/ or wrist spasticity

- No passive movement limitation

- Receiving regular neurodevelopmental rehabilitation

- Sufficient cognitive level

Exclusion criteria:

- Surgery of the upper extremity

- Orthotic treatment

- Sensory deficit

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Kinesiotape plus thenar pressure (PPTG)
In the kinesiotape plus thenar pressure (PPTG). Kinesiotape was applied to control the cortical thumb sign. In addition a piece of plastazote aiming to give thenar pressure was also applied. The amount of pressure was regulated so that the child felt the pressure without being irritated and without restriction in grasping functions.
Taping Group (TG)
In the taping group (TG) kinesiotape was applied to control the cortical thumb sign.

Locations

Country Name City State
Turkey Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nine hole peg test at baseline (before application), at 20 minutes after application, at 20 minutes after application removed Yes
Secondary nine parts puzzle test at baseline (before application), at 20 minutes after application, at 20 minutes after application removed Yes
See also
  Status Clinical Trial Phase
Recruiting NCT06150729 - Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy
Completed NCT02400619 - Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT Phase 1
Completed NCT02261142 - Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS N/A
Completed NCT01945684 - A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity Phase 3
Completed NCT01444794 - Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
Terminated NCT02877836 - Functional MRI and DTI in the Preoperative Assessment of Dystonia N/A
Completed NCT02334683 - Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia N/A
Completed NCT02170779 - Developing and Testing a Comprehensive MS Spasticity Management Program Phase 2
Recruiting NCT05674604 - Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting
Not yet recruiting NCT05926596 - Leg Stretching Using an Exoskeleton on Demand for People With Spasticity N/A
Terminated NCT01712087 - Long-term Surveillance of the MedStream Programmable Infusion System
Completed NCT03906305 - Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients N/A
Completed NCT03302741 - Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings Phase 4
Completed NCT02291159 - Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke N/A
Completed NCT01743651 - Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis Phase 3
Completed NCT01523210 - DTI Study of the Influence of Physiotherapy on Distribution of BoNT in Spastic Muscle N/A
Completed NCT00607542 - Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity Phase 1/Phase 2
Completed NCT00702468 - Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Phase 3
Active, not recruiting NCT04815967 - Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity Phase 2/Phase 3
Completed NCT01457352 - Efficacy and Safety of SPARC0921 in Subjects With Spasticity Phase 3