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Not yet recruitingNCT07517120PEERHOMEcareUpdated Apr 8, 2026

Home-Based Stroke Rehabilitation Using Enriched Environments (PEER-HOMEcare)

An interventional study of Environmental Mapping Tool (using S.T.E.P.S) and Daily Diary in Stroke, sponsored by Norwegian School of Sport Sciences. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Norwegian School of Sport Sciences · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to learn whether the PEERHOMEcare intervention is a feasible and acceptable methodology that may have the potential to improve recovery for adults who are recovering from stroke and receiving rehabilitation at home. PEERHOMEcare adapts research on enriched environments to support brain recovery by creating stimulating and supportive home rehabilitation settings and by involving healthcare professionals and family members. The main questions it aims to answer are whether the PEERHOMEcare approach is feasible to implement in home-based stroke rehabilitation in Norway, Sweden, and Latvia, and whether it improves patient engagement and participation in rehabilitation during the first six months after stroke. Researchers will assess the delivery of the PEERHOMEcare approach to see if the intervention is feasible and acceptable and if the educational material can be used to improve engagement and recovery. Participants will receive home-based stroke rehabilitation, work with project therapists and family members to adapt their home environment to support rehabilitation activities, and complete assessments and follow-up visits to measure engagement, upper limb motor recovery, and feasibility of the intervention.

Read the detailed description

Stroke is a leading cause of long-term disability worldwide and places substantial demands on healthcare systems. Recovery after stroke is influenced by the intensity, frequency, and quality of rehabilitation, particularly during the early months following the event when neuroplasticity is most pronounced. As healthcare systems increasingly shift toward shorter hospital stays and greater reliance on home-based rehabilitation, there is a growing need for innovative approaches that support recovery in the home environment. Research in neuroscience has demonstrated that enriched environments can promote neuroplasticity and functional recovery following brain injury. In animal models, enriched environments typically include increased opportunities for sensory stimulation, social interaction, cognitive engagement, and physical activity. These environments have been associated with improved motor and cognitive outcomes after experimental stroke. Translating these principles into human rehabilitation contexts remains a challenge, particularly within home-based care where environments vary widely and resources may be limited.

The PEERHOMEcare project aims to translate principles of enriched environment research into a structured approach for home-based stroke rehabilitation. The intervention integrates insights from neuroscience, rehabilitation science, and person-centred care to support recovery after discharge from hospital. The approach focuses on enhancing opportunities for activity, engagement, exploration, and participation within the home environment while considering the individual needs, preferences, and daily routines of stroke survivors.

The PEERHOMEcare intervention is designed to be delivered by project therapists in collaboration with patients and family members. The approach emphasises adapting the home environment and daily activities to increase opportunities for physical, cognitive, and social stimulation. Project therapists receive training and guidance on how to apply enriched environment principles in home-based rehabilitation. Families and informal caregivers may also be involved to help support engagement in meaningful activities throughout the day.

A key component of the intervention is the development of practical strategies to integrate rehabilitation activities into everyday routines and environments. Rather than focusing solely on structured therapy sessions, the PEERHOMEcare approach seeks to promote continuous engagement in stimulating activities throughout the day. Environmental modifications, activity planning, and collaborative goal setting are used to encourage participation and independence.

The present study evaluates the feasibility of implementing the PEER-HOMEcare intervention within home-based stroke rehabilitation services in Norway, Sweden, and Latvia. Feasibility evaluation is important before conducting larger-scale effectiveness trials, as it allows researchers to assess the practicality of implementing the intervention in real-world healthcare settings. The study will examine aspects such as the delivery of the intervention by healthcare professionals, integration within existing rehabilitation services, and participant acceptability and engagement with the intervention.

The study is conducted as a multi-country collaboration involving rehabilitation services and research institutions across the three participating countries. The cross-national design allows for exploration of how the intervention can be implemented across different healthcare systems and community care contexts. Findings will inform the refinement of the intervention and the development of implementation guidelines that may support broader adoption of enriched environment principles in home-based stroke rehabilitation.

The results of this feasibility study will contribute to the evidence base for innovative rehabilitation strategies that support recovery after stroke in community settings. If the PEERHOMEcare approach proves feasible and acceptable, it may provide a foundation for future larger trials designed to evaluate the clinical effectiveness and long-term outcomes of the intervention. Ultimately, improving engagement in rehabilitation during the critical early period after stroke may enhance functional recovery, promote independence, and improve quality of life for stroke survivors living at home.

02

Conditions studied

  • Stroke

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Keywords

  • Enriched environment
  • Rehabilitation
  • Home based rehabilitation
  • Upper limb motor function
  • Activities of Daily Living (ADL)
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 45 is close to the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Norwegian School of Sport Sciences is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adults (≥18 years old)
  • diagnosed with first or second haemorrhagic or ischaemic stroke
  • stroke onset no more than six months before study enrolment
  • discharged to their home following inpatient rehabilitation
  • reporting functional impairments in the upper extremity that affect functioning and participation in everyday life due to the latest stroke.
  • score at least 4 points on the Shoulder Abduction + Finger Extension (SAFE) measure.
  • adequate language skills and cognitive functioning to be able to understand intervention material, perform outcome assessments and co-operate throughout the intervention
  • willing to participate and able to provide written consent
  • consent for participation also by closest family members, if they live in the same household

Exclusion criteria

Exclusion Criteria:

  • presence of other neurological conditions
  • reported limited life expectancy due to other medical conditions during the study period
  • severe mental health disorders, including substance use disorders
  • a history of violence
  • severe communication and/or cognition deficits (MoCA below 10 points) that prevent participants from being able to participate in the intervention, understand interview questions, or study-related instructions
  • unwillingness of persons sharing the household to participate and accept the intervention
  • uncontrolled medical issues such as unstable angina, severe hypertension, or severely limiting orthopaedic conditions
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Enriched environment modifications in the home

    Participants in this arm will receive home-based stroke rehabilitation supported by the PEER-HOMEcare approach. The intervention focuses on applying principles of enriched environments to the participant's home setting in order to increase opportunities for physical, cognitive, and social engagement during daily activities. Rehabilitation professionals will work with participants and, when appropriate, family members to identify meaningful activities, adapt the home environment, and integrate stimulating activities into everyday routines. Environmental and activity-based strategies may include modifying the home layout to encourage safe mobility, introducing materials or tasks that promote cognitive and sensory stimulation, and facilitating social interaction and participation in daily life. The goal is to create a home environment that supports exploration, activity, and engagement throughout the day alongside usual home-based rehabilitation services.

    Behavioral: Environmental Mapping Tool (using S.T.E.P.S) · Behavioral: Daily Diary

Interventions

  • BehavioralEnvironmental Mapping Tool (using S.T.E.P.S)

    The environmental mapping tool is used after identifying meaningful tasks with the modified Canadian Occupational Performance Measure (m-COPM). It helps therapists and participants examine how the home environment supports or limits performance of these activities and identify targeted enriched environment (EE) modifications that support rehabilitation goals. Meaningful activities are those that are personally important to the stroke survivor and linked to their identity, independence, roles, or enjoyment, which can enhance motivation and engagement in rehabilitation. The mapping process uses the S.T.E.P.S. framework (Space, Time, Equipment, People, and Safety), to analyse environmental factors influencing task performance. Therapists and participants collaboratively review each activity and consider how the home environment can be adjusted to increase opportunities for safe practice, participation, and engagement in daily life.

  • BehavioralDaily Diary

    The daily diary is used by the stroke survivor to record practice of meaningful activities identified during rehabilitation. It helps ensure that therapy remains focused on the participant's chosen tasks and supports progression by tracking changes in difficulty, level of assistance, and independence over time. The diary also provides a structured record that can be reviewed together with the therapist to reflect on progress, identify challenges, and guide adjustments to activities or environmental strategies to support continued recovery and skill development.

06

What researchers measure

Primary outcomes

  1. Screened Participants

    Will be the number of potential participants that has been screened for eligibility

    Time frame: Post-acute recruitment phase through hospital stay (up to 6 months)

  2. Number of Invited/Number of Accepted Participants

    Will be the number of participants that has been accepted for the trial

    Time frame: Post-acute recruitment phase through hospital stay (up to 6 months)

  3. Number of Eligible Participants

    Will be the number of participants that are eligible for the trial

    Time frame: Post-acute recruitment phase through hospital stay (up to 6 months)

  4. Recruitment Rate

    Will be the number of participants that are recruited for the study. Anticipated 15 participants per country (Norway, Sweden, Latvia) by April 2027

    Time frame: From enrolment to the start of participation in Week 1 (Preparation)

  5. Retention Rate

    Will be the percentage of participants with follow-up data at 3 months. The success criteria for retention is set at 90%.

    Time frame: 3 months after the intervention period (Weeks 2-6)

  6. Completion of first-week study tasks and data collection

    Percentage of participants who complete all required study procedures during the first week of participation. Completion is defined as: identifying at least three goals using the inspired Canadian Occupational Performance Measure (COPM); completing the Barthel Index (BI) questionnaire; successfully being inducted into and using wearable sensors for a minimum of 2 hours per day during the first week; completing all required self-reported and functional assessments; and completing all required environmental mapping data collection points within the participant's home environment. 80% of participants to complete all first-week protocol components.

    Time frame: At the end of Week 1 (Preparation)

  7. Completion and delivery of intervention

    Percentage of participants who receive and complete the required intervention components during the intervention period from Week 2-6. Delivery is defined as: environmental and equipment (EE) modifications implemented by a healthcare professional using our STEPS approach on at least 5 occasions during the intervention period; completion of regular home visits with a minimum frequency of one visit per week; participant use of wearable sensors for at least 2 hours per day, with successful adherence defined as more than 7 hours of sensor use per week (maximum expected use 10 hours per week); and completion of participant diary entries on at least 3 out of 5 days per week for the duration of the intervention period.

    Time frame: At the end of the Week 6 (Intervention)

  8. Acceptability Questionnaire (Stroke Survivor and Family Member)

    This questionnaire is a self-report measure for individuals with stroke and their family members that evaluates their experience with the PEER-HOMEcare intervention. It assesses how acceptable, beneficial, and engaging the treatment was, including participation, communication with therapists, motivation, and the ability to adapt daily activities and the home environment. Using a 4-point scale, it also captures perceptions of specific components such as home-based care, use of sensors, digital materials, and involvement of family, as well as the overall impact on daily functioning and goal achievement. The target is 80% answer "very much" or "entirely".

    Time frame: At the end of treatment (Week 6)

  9. Collection and Interpretation of Sensor Data

    Percentage of intervention weeks in which sensor technology is successfully used and managed as intended. This includes weekly downloading of sensor data, collection of usable sensor data, and discussion of sensor-derived measurements within the healthcare professional team to inform environmental and equipment (EE) modifications. Usable data are defined as sensor recordings that meet the required quality and completeness criteria for interpretation by the healthcare professional. Success is defined as weekly downloading of sensor data (100% completion), at least 80% of collected sensor data during the intervention period being usable, and sensor measurements being discussed within the team at least once per week to support intervention decisions.

    Time frame: From Week 2 to the end of treatment (Week 6).

  10. Use of educational resources

    Percentage of participants who access and use the study educational resources during the intervention period. Educational resources include the study webpage and laptop provided for accessing the patient portal. Use of the resources will be assessed by tracking participant logins to the patient portal. Successful engagement is defined as participants signing into the patient portal at least three times during the intervention period.

    Time frame: From enrolment through until the 3 month follow-up.

  11. Fidelity to the intervention protocol by project therapists

    Percentage of intervention sessions in which project therapists adhere to the study protocol, assessed using a structured fidelity log. Therapists will complete the fidelity log to document adherence to the planned intervention procedures. Fidelity will be evaluated at least two times during the intervention period. A high level of fidelity is defined as a score of at least 85% on the fidelity log, indicating that the intervention components were delivered according to the protocol.

    Time frame: During the preparation (Week 1) and intervention period (Weeks 2-6), reviewed at least twice during the project period.

  12. Participant adherence to intervention activities

    Percentage of participants who adhere to the planned intervention activities related to their identified goals (inspired m-COPM). Adherence is defined as participants performing activities related to their individualised goals and following the STEPS-based environmental and equipment modifications as agreed upon with the healthcare professional. Successful adherence is defined as engaging in these goal-related activities at least five times per week.

    Time frame: During the intervention period (weeks 2-6 of study participation).

  13. Acceptability Questionnaire (Therapist)

    This questionnaire is a therapist-completed assessment of how the patient experienced and engaged with the PEER-HOMEcare intervention. It evaluates the therapist's perception of the patient's participation, motivation, understanding, and acceptance of the treatment, as well as the perceived benefits for daily functioning. Using a 4-point scale, it also covers aspects such as communication, adaptability to new activities and home modifications, use of sensors and digital materials, and the patient's likelihood of continuing learned strategies after the intervention. The target is 80% answer "very much" or "entirely".

    Time frame: At the end of treatment (Week 6)

  14. Action Research Arm Test (ARAT)

    The Action Research Arm Test is a 19-item observational assessment of upper extremity motor function in individuals with stroke. The test evaluates grasp, grip, pinch, and gross arm movement. Each item is scored on a 4-point ordinal scale from 0 to 3, producing a total score ranging from 0 to 57, where higher scores indicate better upper limb motor function.

    Time frame: Baseline/Preparation (Week 1) and end of treatment (Week 6)

  15. Fugl-Meyer Assessment Upper Extremity (FMA-UE)

    The Fugl-Meyer Assessment for Upper Extremity is a standardised, performance-based measure used to assess motor recovery after stroke. The full assessment evaluates motor function, sensation, joint range of motion, and pain in the upper limb. Total scores range from 0 to 66, where higher scores indicate better motor and neurological function.

    Time frame: Baseline/Preparation (Week 1) and end of treatment (Week 6)

  16. Abilhand

    The ABILHAND is a patient-reported outcome measure assessing perceived difficulty in performing manual activities using one or both hands. Participants rate activities as impossible, difficult, or easy. Responses are converted using Rasch analysis to produce a linear ability measure. Higher scores represent better perceived manual ability.

    Time frame: Baseline/Preparation (Week 1) and end of treatment (Week 6)

  17. The Stroke Self-Efficacy Questionnaire (SSEQ)

    The Stroke Self-Efficacy Questionnaire is a patient-reported outcome measure assessing confidence in performing functional activities and managing life after stroke. The scale includes 13 items scored from 0 to 10, with total scores ranging from 0 to 130, where higher scores indicate greater self-efficacy.

    Time frame: Baseline/Preparation (Week 1) and end of treatment (Week 6)

  18. Stroke Impact Scale (SIS)

    The Stroke Impact Scale is a 59-item patient-reported questionnaire assessing the impact of stroke across eight domains: strength, hand function, activities of daily living, mobility, communication, emotion, memory, and participation. Domain scores range from 0 to 100, where higher scores indicate better health status and function.

    Time frame: Baseline/Preparation (Week 1) and end of treatment (Week 6)

  19. Barthel Index (BI)

    The Barthel Index is a 10-item measure of independence in activities of daily living, including feeding, bathing, grooming, dressing, toileting, transfers, mobility, and stair use. Scores range from 0 to 100, where higher scores indicate greater independence in daily activities.

    Time frame: Baseline/Preparation (Week 1) and end of treatment (Week 6)

  20. Patient Health Questionnaire - 9 (PHQ-9)

    The Patient Health Questionnaire is a 9-item self-report measure used to screen for and assess the severity of depressive symptoms. Total scores range from 0 to 27, where higher scores indicate more severe depressive symptoms.

    Time frame: Baseline/Preparation (Week 1) and end of treatment (Week 6)

  21. General Anxiety Disorder - 7 (GAD-7)

    The Generalised Anxiety Disorder is a 7-item self-report questionnaire used to assess the severity of anxiety symptoms. Total scores range from 0 to 21, where higher scores indicate greater anxiety severity.

    Time frame: Baseline/Preparation (Week 1) and end of treatment (Week 6)

Secondary outcomes

  1. Entropy - A measure of variability of the upper limb

    Entropy is used to quantify variability in upper limb movement during daily activities using data from wearable sensors. Entropy reflects how varied or predictable movement patterns are over time: higher entropy values indicate greater variability in movement, while lower values indicate more repetitive or consistent movement patterns. Entropy will be calculated using acceleration and orientation data from upper limb segments (general entropy) and orientation data alone to represent joint movement variability (joint entropy). Measures will be calculated either across all monitored upper limb segments or specifically for the affected upper limb. Entropy values do not have a fixed upper limit. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or week).

    Time frame: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant). Data will be extracted and analysed once per week.

  2. Novelty - A measure of new movements

    Novelty measures the occurrence of new upper limb movement patterns during daily activities. It is defined as the percentage of time in which previously unobserved segment orientations of the upper limb are detected using wearable sensors. A higher percentage indicates that a participant performed more new movement configurations, while lower values indicate fewer newly observed movements. Novelty is used to determine whether increased exploration of movement (e.g., variability measured by entropy) leads to the emergence of new movement behaviours. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or week).

    Time frame: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.

  3. Smoothness - A measure of fluidity of the upper limb

    Smoothness measures the fluidity and coordination of upper limb movements during daily activities using wearable sensor data. The measure reflects how continuous and harmonious movements are and is influenced by factors such as changes in direction, jerkiness, abrupt movements, and variations in acceleration. Smoothness is derived from sensor-based movement data from the upper limb segments. A value of 0 represents completely smooth movement, while negative values indicate less smooth movement, reflecting increased jerkiness or abrupt changes in motion. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or week).

    Time frame: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.

  4. Compensation - A measure of the trunk to assist the affected upper limb

    Compensation measures the extent to which trunk movements are used to assist or compensate for movements of the affected upper limb during daily activities. It is calculated using wearable sensor data as the percentage of time that the trunk and the affected upper limb move simultaneously, indicating compensatory trunk involvement during arm movements. Scores range from 0% to 100%, where 0% represents no trunk compensation (movement of the upper limb occurs without concurrent trunk movement) and higher percentages indicate greater use of trunk compensation. Sensor data from the trunk and upper limb segments are analysed to determine when these segments move together. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or week). A reduction in compensation over time is expected during the intervention.

    Time frame: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.

  5. Use of the affected limb

    Use of the affected upper limb measures the percentage of time the affected arm is active during daily activities, as detected by wearable sensors placed on the upper limb segments. Movement is identified through sensor-derived acceleration and orientation data, indicating when the affected limb is being used. Scores range from 0% to 100%, where 0% indicates no detected use of the affected limb and 100% indicates continuous use during the monitored period. Higher percentages represent greater use of the affected arm in everyday activities. Sensor data can be extracted across different time increments (e.g., 10 minutes, 20 minutes, 1 hour, day, or week).

    Time frame: Weekly measurements collected during the intervention period (Weeks 2-6 for each participant), with data extracted once per week.

Other outcomes

  1. Shoulder Abduction and Finger Extension (SAFE)

    The Shoulder Abduction and Finger Extension score is a clinical tool used to predict upper limb function and muscular strength. It assesses the strength from excellent to poor of shoulder abduction and finger extension using a scale (0-5), with the combined scores (0-10), where higher scores indicate greater muscle strength and better motor function. It will be used as a screening tool upon enrolment, with participants need to score at least 4/10 points.

    Time frame: At screening (prior to enrolment, during baseline eligibility assessment).

  2. The Montreal Cognitive Assessment (MoCA)

    The Montreal Cognitive Assessment is a 10-minute screening tool used to detect mild cognitive impairment (MCI), assessing domains like memory, executive function, and orientation. Scored out of 30, a score of 26 or higher is considered normal cognitive function, developed to identify subtle cognitive changes. Participants must score 10 or higher to be eligible for the study.

    Time frame: At screening (prior to enrolment, during baseline eligibility assessment).

  3. Modified Rankin Scale (mRS)

    The Modified Rankin Scale is a 7-level clinician-reported scale (0-6) used to measure the degree of disability or dependence in daily activities for stroke survivors, ranging from no symptoms (0) to death (6). Participants would need to from 0-3 or 4, depending on their level of support.

    Time frame: At screening (prior to enrolment, during baseline eligibility assessment).

  4. Adverse Events

    We want to report on any serious adverse events during the intervention. The target is to have no detected adverse events (falls and injuries etc).

    Time frame: From Week 1 to Week 6

07

Study locations

3 sites
  • Riga Stradins University Hospital
    Riga, Latvia
  • Sunnaas Rehabilitation Hospital
    Nesoddtangen, Norway
  • Sahlgrenska University Hospital
    Gothenburg, Sweden
08

References and documents

Publications

  • Nasilowska M. [Intestinal parasites 1985]. Przegl Epidemiol. 1987;41(1):131-7. No abstract available. Polish. PubMed 3671747 ↗
  • Oppici L, Berzina G, Hestetun-Mandrup AM, Lovstad M, Opheim A, Pacheco MM, Rafsten L, Sunnerhagen KS; PEER-HOMEcare consortium; Rudd JR. A Scoping Review of Preclinical Environmental Enrichment Protocols in Models of Poststroke to Set the Foundations for Translating the Paradigm to Clinical Settings. Transl Stroke Res. 2025 Oct;16(5):1850-1873. doi: 10.1007/s12975-025-01335-3. Epub 2025 Feb 6. PubMed 39913056 ↗
  • Opheim A, Oppici L, Hestetun-Mandrup AM, Sunnerhagen KS, Rafsten L, Berzina G, Karklina A, Lovstad M, Ora HP, Marcos L, Pacheco M, Fernandes A, Sorensen L, Rudd JR. Pedagogy and Enriched Environment for Rehabilitation in the HOME After Stroke (PEER-HOMEcare): Study Protocol for a Single-Group Feasibility Study. Transl Stroke Res. 2026 Jun 16;17(4):68. doi: 10.1007/s12975-026-01459-0. PubMed 42301578 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 23, 2026
  • Informed consent form · Feb 16, 2026
  • Informed consent form · Feb 16, 2026
  • Informed consent form · Feb 16, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — IPD data will not shared before anonymisation

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07517120
Lead sponsor
Norwegian School of Sport Sciences
Collaborators
Sunnaas Rehabilitation Hospital, Göteborg University, Riga Stradins University
Responsible party
James Robert Rudd (Professor, Norwegian School of Sport Sciences) — Principal investigator
First posted
Apr 8, 2026
Start date
Mar 15, 2026 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Apr 8, 2026

Study contacts

James R Rudd, Professor
Contact
jamesr@nih.no
+47 46767926
Arve I Opheim, Associate Prof.
Contact
arve.opheim@sunnaas.no
+47 98005122
James Rudd, Professor
principal investigator · Norwegian School of Sport Sciences (NIH)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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