MedDataX Logo

Occupational Therapy and Cognitive Challenges After Brain Injury

NCT ID: NCT05148247

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2024-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background: There is a need for standardized interventions in community rehabilitation that can improve everyday task performance for older adults with cognitive challenges after acquired brain injury. Older adults are often excluded from research due to strict inclusion criteria. It is critical for a sustainable health service system that these patients are empowered and reach their maximum level of independence. The Perceive, Recall, Plan and Perform System (PRPP) of Intervention can be applied by Occupational Therapists (OT) for clients with cognitive challenges to enhance mastery of needed or desired everyday tasks. There is no current evidence for the effectiveness of this intervention for this population.

Purpose: A clinical trial to investigate the effectiveness of the PRPP intervention for older persons with cognitive impairments after brain injury in the context of community-based rehabilitation.

Method: In PRPP intervention the OT uses systematically instructions in task training to support a client to use cognitive strategies efficiently. The everyday tasks used for training should be valued by the participant and useful in their rehabilitation. The tasks could include different parts of morning routines, simple or complex meal planning or preparation, use of cell phone, leisure activities, or other household and community activities. At best the skills are generalized throughout all everyday activities, and the OTs' role as a cognitive mediator fades as participants internalize the strategies. The participants receive PRPP intervention 3 times a week for 3 weeks, every session last for 45-60 minutes.

The participants' task mastery and cognitive strategy use will be measured at least 5 times in each phase: baseline, intervention, after the intervention, and 4 weeks after the discharge from rehabilitation. The measurement scores at baseline act controls and are therefore compared with the other phases for the same participant. The same procedure will be repeated for the other participants, but then with a staggered intervention phase. A staggered intervention phase acts as a control between participants and allows to see if changes occur only when the intervention is introduced.

Implications for practice: The investigators assume that this systematic intervention will improve everyday task performance, and will in turn contribute to empowerment and independence of older adults with cognitive challenges after brain injuries.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Injuries Cognitive Impairment

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Task Performance Occupational Therapy Community Health Services Elderly The Perceive, Recall, Plan and Perform System Rehabilitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-Case Experimental Designs with Multiple baselines across participants. At least five data collection points within 4 phases (= at least 20 data points) for each participant (= one tier), and a minimum of three participants (= one sample), is recommended to meet design quality standards. The 'Number of Arms' will in this tradition mean one tier. Data for at least 2 samples will be collected, each of 3 tiers.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants are randomized to three different baseline-lengths in each tier, that serve as control data in this design. Blinding is not possible for the conducting OT, but an independent PRPP-trained OT assesses 20 % of the PRPP stage 1 and 2 measurements from each phase by videotaping the assessment situations. The tapes will be presented blinded and randomly for this second and blinded assessor.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PRPP Intervention

This baseline phase will be 3, 5 or 7 days, and intervention phase starts immediately after baseline with 45-60 minutes PRPP Intervention 3 times a week for 3 weeks.

Group Type EXPERIMENTAL

The Perceive, Recall, Plan and Perform System of Intervention

Intervention Type BEHAVIORAL

The aim of the PRPP intervention is to enhance mastery in performance of needed or desired occupations, and extend traditional task training. Systematic instructions to support the clients' cognitive capacity to think about doing in different tasks and contexts are given by the OT, based on the results of PRPP Assessment stage 2. Further, the OT uses graded verbal, visual or physical prompts and cues directly during the participants task performance, progressing from content-free meta-prompts 'Stop' to alert the participant to process information required for the task, and for errorless learning. Then the OT prompt 'sense/attend, think and do', to more specific behavioural prompts selected by the therapist based on the components from the PRPP Assessment stage 2. At best the skills are generalized throughout all everyday activities, and the OTs' role as a cognitive mediator fades as the person internalize the strategies.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The Perceive, Recall, Plan and Perform System of Intervention

The aim of the PRPP intervention is to enhance mastery in performance of needed or desired occupations, and extend traditional task training. Systematic instructions to support the clients' cognitive capacity to think about doing in different tasks and contexts are given by the OT, based on the results of PRPP Assessment stage 2. Further, the OT uses graded verbal, visual or physical prompts and cues directly during the participants task performance, progressing from content-free meta-prompts 'Stop' to alert the participant to process information required for the task, and for errorless learning. Then the OT prompt 'sense/attend, think and do', to more specific behavioural prompts selected by the therapist based on the components from the PRPP Assessment stage 2. At best the skills are generalized throughout all everyday activities, and the OTs' role as a cognitive mediator fades as the person internalize the strategies.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PRPP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Admission to the health centres in the two municipalities
* Acquired brain injury
* Mastery under 85% of PRPP Assessment stage 1

Exclusion Criteria

* An already diagnosed dementia or progressive brain disorder
* Congenital brain injury or neurological developmental disorder
* Not able to understand or hear instructions, due to foreign language, severe hearing loss or severe arousal problems
* Physical disabilities that hinder performance of most daily activities.
* If a participant show mastery above 85% of PRPP Assessment stage 1, the participant either need to be assessed in more taxonomic difficult activities or will be excluded with 'no cognitive challenges in occupational performance'.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Østre Toten Municipality

UNKNOWN

Sponsor Role collaborator

Skien Municipality

UNKNOWN

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Heidi Vifladt

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Østre Toten Municipality, Department of Physio- and Occupational Therapy

Lena, , Norway

Site Status

Skien Municipality, Department of Rehabilitation and Palliative Care

Skien, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

Porcino AJ, Shamseer L, Chan AW, Kravitz RL, Orkin A, Punja S, Ravaud P, Schmid CH, Vohra S; SPENT group. SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist. BMJ. 2020 Feb 27;368:m122. doi: 10.1136/bmj.m122. No abstract available.

Reference Type BACKGROUND
PMID: 32107202 (View on PubMed)

Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. J Clin Epidemiol. 2016 May;73:142-52. doi: 10.1016/j.jclinepi.2016.04.006. Epub 2016 Apr 19.

Reference Type BACKGROUND
PMID: 27101888 (View on PubMed)

Lindstad MO, Obstfelder A, Sveen U, Stigen L. Effectiveness of the PRPP Intervention after brain injury in home-based rehabilitation: Single-case experimental designs with multiple baselines. Scand J Occup Ther. 2025 Jan;32(1):2444591. doi: 10.1080/11038128.2024.2444591. Epub 2025 Jan 2.

Reference Type DERIVED
PMID: 39744963 (View on PubMed)

Lindstad MO, Obstfelder AU, Sveen U, Stigen L. Feasibility of the Perceive, Recall, Plan and Perform system of intervention for persons with brain injury in community-based rehabilitation: a pilot for a multiple-baseline design study. BMJ Open. 2023 Jun 28;13(6):e067593. doi: 10.1136/bmjopen-2022-067593.

Reference Type DERIVED
PMID: 37380207 (View on PubMed)

Lindstad MO, Obstfelder AU, Sveen U, Stigen L. Effectiveness of the Perceive, Recall, Plan and Perform intervention for persons with brain injury in community-based rehabilitation: protocol for a single-case experimental design with multiple baselines. BMJ Open. 2022 Oct 5;12(10):e060206. doi: 10.1136/bmjopen-2021-060206.

Reference Type DERIVED
PMID: 36198473 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REK 215391

Identifier Type: -

Identifier Source: org_study_id