Evaluation of the Ronnie Gardiner Method in Individuals With Stroke in Late Phase of Recovery
NCT06979050, Not applicable, Active not recruiting, Göteborg University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of the Ronnie Gardiner Method in Individuals With Stroke in Late Phase of Recovery | ClinicalTrials.gov |
| NCT number | NCT06979050 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Göteborg University | ClinicalTrials.gov |
| Conditions | Stroke | ClinicalTrials.gov |
| Interventions | The Ronnie Gardiner Method | ClinicalTrials.gov |
| First posted | 2025-05-18 | ClinicalTrials.gov |
| Last updated | 2025-10-03 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Balance performance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest) | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The mini-BESTest (Mini Balance Evaluation Systems Test) is a shortened version of the BESTest, designed to assess balance and functional mobility, especially in individuals with neurological or musculoskeletal conditions. It focuses on balance deficits across domains like postural control, gait, stability, and anticipatory responses. With 14 items compared to the original 36, the mini-BESTest is quicker to administer, making it more practical for clinical use. It evaluates four main balance systems: * Anticipatory Postural Adjustments: Preparing and adjusting posture for movements. * Reactive Postural Control: Responding to unexpected balance challenges. * Sensory Orientation: Using sensory input (like vision and proprioception) for balance. * Dynamic Gait: Stability and efficiency while walking, including maintaining balance during movement. Minimum score is 0 points, maximum score is 28 points. Higher scores indicate better balance control. | ClinicalTrials.gov |
| Secondary | Concern about falling measured by the Falls Efficacy Scale-International (FES-I) | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | FES-I is a tool used to assess a person's confidence in performing daily activities without falling. It consists of 16 questions that cover a range of activities, from walking and bathing to social interactions. The scale helps identify individuals who may have a fear of falling, which can impact their participation in everyday life. Minimum score is 16 points, maximum score is 64 points. A higher score indicates greater concern about falling, and it's commonly used in older adults or individuals at risk of falls to guide interventions aimed at improving balance and reducing fall risk. | ClinicalTrials.gov |
| Secondary | Working memory measured by the Memory Test (Immediate and Delayed Recall) | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The test assesses the ability to recall a read text immediately after it is read aloud and after a few minutes, when another test is conducted (delayed recall). | ClinicalTrials.gov |
| Secondary | Cognitive flexibility and inhibitory control measured by the Victoria Stroop Test | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | Measures cognitive flexibility, attention, and response inhibition. It involves naming the color of printed words that may or may not match the color they describe, requiring the individual to suppress automatic reading responses. The test is commonly used to assess executive function, particularly in individuals with neurological conditions. It includes three conditions, and outcomes include reaction time and number of errors. Higher interference scores indicate poorer inhibitory control. | ClinicalTrials.gov |
| Secondary | Visuospatial memory and organization measured by the Rey-Osterrieth Complex Figure Test | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The Rey-Osterrieth Complex Figure Test is a neuropsychological assessment used to evaluate visuospatial abilities, memory, attention, and executive function. Individuals are asked to copy a complex geometric figure and later reproduce it from memory after a delay. It is commonly used to assess cognitive impairments in various neurological conditions. Scoring is based on accuracy and placement of figure components. Higher scores indicate better visuospatial memory and organizational performance. | ClinicalTrials.gov |
| Secondary | Physical performance measured by the Short Physical Performance Battery (SPPB) | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | A clinical tool used to assess lower extremity function and mobility in older adults. It includes tests of balance, gait speed, and chair stands to evaluate physical performance. The SPPB is commonly used to predict disability, falls, and overall functional decline. Minimal score is 0 points, maximum score is 12 points. Higher score indicates better physical function. | ClinicalTrials.gov |
| Secondary | Functional mobility and gait performance measured by the 10-Meter Walk Test (10MWT) | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The 10-Meter Walk Test (10MWT) is a quick assessment used to measure walking speed over 10 meters at the individual's self-selected pace. It evaluates functional mobility, gait efficiency, and balance. The test is commonly used to monitor progress and predict functional outcomes in people with neurological or musculoskeletal conditions. | ClinicalTrials.gov |
| Secondary | Physical capacity including aerobic capacity and endurance measured by the 6-Minute Walk Test (6MWT) | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The 6-Minute Walk Test (6MWT) measures the distance an individual can walk at a self-paced speed over six minutes. It assesses aerobic capacity, endurance, and functional mobility. The test is widely used to evaluate cardiovascular and pulmonary function in clinical and rehabilitation settings. The test measures the distance a person can walk in six minutes on a flat, hard surface, typically a 30-meter course. | ClinicalTrials.gov |
| Secondary | Upper extremity function measured by The Observational Drinking Task Assessment | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The Observational Drinking Task Assessment is used to evaluate upper limb function, motor control, and coordination during a simulated drinking task. The individual is observed while reaching for, grasping, and bringing a cup to the mouth. It is often used in neurological rehabilitation to assess functional use of the affected arm. Minimal score is 0 points, maximal score is 15 points. Higher scores indicate worse outcome, i.e., more impairments in the upper extremity. | ClinicalTrials.gov |
| Secondary | Finger dexterity and fine motor skills measures by the 9-Hole Peg Test (9HPT) | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The 9-Hole Peg Test is a standard assessment used to measure finger dexterity and fine motor skills. The individual is required to place and remove pegs from a pegboard as quickly as possible. It is commonly used to assess hand function in individuals with neurological conditions, such as multiple sclerosis or stroke. | ClinicalTrials.gov |
| Secondary | Health-related quality of life and functional recovery after a stroke measured by the Stroke Impact Scale 16 (SIS-16) | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The Stroke Impact Scale 16 (SIS-16) is a self-reported questionnaire used to assess the health-related quality of life and functional recovery after a stroke. It consists of 16 items that measure various aspects of physical, emotional, and social functioning. The scale helps track recovery progress and guide rehabilitation in stroke survivors. Minimal score is 16 points, and maximum is 80. Higher score indicates a better function and lower impact on everyday life. | ClinicalTrials.gov |
| Secondary | Severity of depressive symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered assessment used to evaluate the severity of depressive symptoms. It consists of 10 items that assess mood, sleep, appetite, and other emotional and physical symptoms associated with depression. The MADRS is commonly used in clinical settings to monitor treatment progress and assess depression severity. Minumum score is 0 points, and maximum score is 60. Higher scores indicate more severe symptoms of depression. | ClinicalTrials.gov |
| Secondary | General health-realted quality of life measured by the Research and development (RAND) 36-item health survey | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The RAND-36 is a health survey used to assess an individual's overall health-related quality of life. It consists of 36 items that measure eight domains, including physical functioning, emotional well-being, social functioning, and general health perceptions. The RAND-36 is widely used in both clinical and research settings to evaluate health outcomes across various conditions. Minimal score is 0 points, maximal score is 100 points. Higher values indicate better self-reported health-related quality of life. | ClinicalTrials.gov |
| Secondary | Cost-effectiveness evaluated with the standardized European Quality of Life (EuroQol) questionnaire with 5 dimensions | At baseline, at 12 weeks (end of intervention), and at 24 weeks (3-month follow-up) | The EuroQol 5D 5L (EQ-5D-5L) is a standardized instrument used to assess health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity. The EQ-5D-5L is commonly used in clinical trials, healthcare evaluations, and to measure the impact of treatments on patients' well-being. Minimal score is 0 on a visual analogue scale, and 100 is maximum. A higher score indicates better health in general. Scores is used to evaluate an interventions cost-effectiveness. | ClinicalTrials.gov |
| Other | Various cognitive domains measured by the Montreal Cognitive Assessment (MoCA) | Only at baseline | The Montreal Cognitive Assessment (MoCA) is a screening tool used to assess cognitive function and detect mild cognitive impairment. It evaluates various cognitive domains, including memory, attention, language, visuospatial skills, and executive function. The MoCA is commonly used in clinical settings to identify early signs of cognitive decline, such as in Alzheimer's disease or other neurodegenerative conditions. In our study, it will be used as an inclusion criterion. Minimal score is 0 points, maximum score is 30 points. In our study, a score of 25 is required to be included in the study. The MoCA is only used as a screening tool at baseline. | ClinicalTrials.gov |
| Other | Participants' enjoyment of the interventions measured by the Physical Activity Enjoyment Scale (PACES) | After 12 weeks of treatment | The Physical Activity Enjoyment Scale (PACES) is a tool used to assess an individual's enjoyment of physical activity. It consists of several18 items that measure positive and negative feelings associated with engaging in physical exercise. PACES is commonly used in research and clinical settings to understand motivation and promote long-term adherence to physical activity. Minimal score is 18 points, and maximum score is 126 points. Higher score indicates higher enjoyment of the intervention. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41638729 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)