The Effect of the CO-OP Approach for Children With Cerebral Palsy

NCT04308200 | Completed

• 1 other identifier: GO 18/624
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

In the literature, despite the reported positive findings of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, studies in this area have been limited and it is stated that studies involving more sample groups are needed (24-27). In addition, no studies investigating the effect of the CO-OP approach on functional status were found. The purpose of this study was to investigate the effects of CO-OP approach in terms of occupational performance and satisfaction also functional status in children with cerebral palsy (CP) and to determine parents' satisfaction level from CO-OP. The hypotheses of the study are: The CO-OP approach has no effect on occupational performance in children with CP. CO-OP approach has no effect on occupational satisfaction in children with CP. The CO-OP approach has no effect on the functional status of children with CP.

Conditions

Cerebral Palsy; Cognitive Orientation

Keywords

Cerebral Palsy; Cognitive Orientation; occupations; functional status

Outcome Measures

Primary Outcomes (2)

• Canadian Occupational Performance Measure (COPM)

  The COPM was used in this study to establish goals for each child prior to intervention. It is a semi-structured interview designed to help clients identify occupational performance issues and priorities in the areas of self-care, productivity (school), and leisure, in which they have difficulty performing. In this study, children and their parents selected the "training goals" collaboratively by rating on a 10-point scale displaying their goals in terms of satisfaction and performance. The children and their parents scored the COPM independently before and after intervention based on goals set by the child and supported by the parents. Changes in performance and satisfaction scores before and after intervention were determined separately. A change score of two points or more on the COPM is considered clinically significant

  It was re-applied 5 weeks after the baseline evaluations were made.

• Pediatric Evaluation of Disability Inventory (PEDI)

  PEDI is a clinical measurement tool developed by Haley et al to evaluate the functional status of children. In particular, it is arranged to determine the functions of young children . It can also be used for older children whose functional performance falls below that expected for 7.5- year-old normally developing children. PEDI consists of three main sections, functional skills, caregiver assistance and modifications. Each of these sections evaluates the areas of self-care, mobility and social function. Each of the PEDI subsections can be used separately.

  It was re-applied 5 weeks after the baseline evaluations were made.

Secondary Outcomes (1)

• Visual Analog Scale (VAS)

  It was applied to the caregivers of the CO-OP + NDT group within 1 days after 5 weeks of training.

Study Arms (2)

CO-OP+NDT group

OTHER

The CO-OP+NDT group received twelve sessions of CO-OP approach, with the baseline and end of treatment assessments, each lasting approximately one hour. Parents and / or caregivers were advised to observe sessions as often as possible to encourage adaptation and transfer to life. Furthermore, CO-OP+NDT group received NDT for 45 minutes once daily, two times a week for period of 6 weeks by the same physiotherapist.

Other: CO-OP approach; Other: NDT

NDT group

OTHER

NDT group received just NDT for 45 minutes once daily, two times a week for period of 6 weeks by the same physiotherapist. The NDT protocol is improving muscular tone and movement patterns. All sessions incorporated handling techniques that aimed to alter muscle tone during movement and to facilitate anti-gravity and postural reactions.

Other: NDT

Interventions

CO-OP approach OTHER

There are 3 stages in the CO-OP approach. Stage I, the Preparation Stage, is primarily concerned with establishing the "goal". Before the first interview, the child was contacted, the family and the child were informed, and it was checked whether they met the prerequisites. At this stage, 3 targets were selected and the basic performance level was determined. Stage II, the Acquisition Stage, is essentially the "plan" and "do" stage, in which the work of using strategies to acquire skills is done. This stage originally comprised 10 sessions. At this stage, the first session enabling principles were implemented and the global strategy "goal-plan-do-check" was introduced. The family attended this process with observation. Parents / caregivers were encouraged to make observations to generalize strategies. Stage III, the Verificatíon stage usually consists of only one session in which "control" is performed; the progress made was revised as learned strategies.

CO-OP+NDT group

NDT OTHER

All participations received NDT for 45 minutes once daily, two times a week for period of 6 weeks by the same physiotherapist. The NDT protocol is improving muscular tone and movement patterns. Although the treatment activities varied for each CP participant, the overall goals (improved smoothness and efficiency of movement), which included improved trunk, hip, knee and ankle control, were the same for all CP participants. All sessions incorporated handling techniques that aimed to alter muscle tone during movement and to facilitate anti-gravity, weight-shifting and postural reactions.

CO-OP+NDT group; NDT group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• being between 5-12 years of age
• being diagnosed with CP
• being at level I, II, or III according to the Gross Motor Function Classification Scale (GMFCS)
• being at level I, or II according to the Manual Ability Classification System (MACS)
• having experienced motor performance problems in daily activities, as reported by parents and/or children during interview; have sufficient language ability to communicate with and be understood during treatment.

You may not qualify if:

• receiving another treatment other than NDT
• being diagnosed with mental retardation
• having serious visual or hearing problems.

Sponsors & Collaborators

• ZEYNEP KOLİT: lead

Study Sites (1)

Hacettepe University

Ankara, Sıhhiye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Orientation, Spatial

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spatial Behavior; Behavior

Study Officials

• Zeynep Kolit, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Gamze Ekici Çağlar, PhD

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study was a single blinded and randomized controlled trial. All children included in the study were evaluated by a single evaluator who was blind to therapy at baseline and at the end of treatment. The study was completed with a total of 30 individuals, 15 in the CO-OP+ neurodevelopmental therapy (NDT) and 15 in the NDT group. Both groups received NDT for 45 minutes once daily, two times a week for period of 6 weeks by the same physiotherapist. The NDT protocol is improving muscular tone and movement patterns. All sessions incorporated handling techniques that aimed to alter muscle tone during movement and to facilitate anti-gravity and postural reactions. All children who met the inclusion criteria using GMFCS and MACS were evaluated with sociodemographic data, activity daily log, COPM and PEDI. The CO-OP group received twelve sessions of intervention, with the baseline and end of treatment assessments, each lasting approximately one hour.

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 13, 2020
• Study Start: October 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: August 2, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)