StrokeNCT02889939
High-intensity Training in an Enriched Environment in Late Phase After Stroke
A study testing UC + ETT in people with Stroke and Brain Diseases, run by Göteborg University at 1 site in Sweden.
Trial summary
We designed an explorative clinical study to assess the effectiveness of an enriched intense and task-oriented therapy program in enhancing motor recovery in patients with moderate to moderately severe hemiplegia after stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Brain Diseases
- What is being tested?
- UC + ETT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least six months and maximum 10 years after the onset of stroke
- Disability grade between 2 and 4 on the Modified Rankin Scale.
- Some degree of hemiparesis, according to the primary outcome measure M-MAS UAS -99, at baseline.
- Approved by the referring / prescribing physician for intensive training
- Medically stable considering cardiovascular conditions
- Cognitive and speech ability that enables instruction, intervention and evaluation
- Ability and willingness to travel to the place of evaluation
- Able to perform sitting transfers independently or with manual assistance
Who cannot join
- Exercise-induced epilepsy.
- Injury, illness or addiction, making the individual unsuitable for participation.
- Having participated in an intense comprehensive rehabilitation program (additional to post-stroke acute- and subacute rehabilitation) at some point within the past six months.
- Scheduled for other treatment with focus on intensive training during the study.
- Use of assistive technology for sitting transfers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of High-intensity, Task Specific Training Combined With Environmental Enrichment for Individuals in a Late Phase After Stroke
We designed an explorative clinical study to assess the effectiveness of an enriched intense and task-oriented therapy program in enhancing motor recovery in patients with moderate to moderately severe hemiplegia after stroke. This enriched comprehensive task-specific therapy (ETT) program combines intensive and task-specific therapy with the sensory-motor, social, and cognitive stimulation inherent to environmental enrichment. We also investigated whether ETT improves gait, balance, upper and lower limb function, and confidence in task performance, health-related quality of life (HRQoL) and reduces fatigue and depression.
Read the detailed description
Background The brain has a limited ability for repair. However, in recent years it became evident that a remarkable, yet restricted ability for regeneration of neuronal connections exists, with positive implications for the rehabilitation of individuals with stroke. Several studies have shown that stroke-lesioned animals, which are exposed to a so called enriched environment (large cages, group housing of animals, equipped with toys and with possibilities for physical activity and social interactions) show signs of tissue regeneration/plasticity in the brain. Research has shown that rats exposed to this enriched environment are recovering significantly faster from stroke than rats in standard cages, despite the fact that the total tissue loss between the rats did not differ.
Recovery and improvement of motor functions and skills after stroke depend on spontaneous repair processes but also on the reorganization of neural mechanisms by stimuli and demands that are placed on the motor control system. In spite of numerous research studies showing that functional recovery after stroke is possible even many years after the stroke onset, it is unusual for stroke victims to be offered any kind of rehabilitation during later stages.
The combination of modalities in multimodal interventions is thus expected to have a synergistic effect on neuroplasticity in rehabilitation after stroke in humans. In a recent clinical trial, multimodal interventions based on rhythm and music or therapeutic horseback riding improved recovery in the late phase after stroke Nevertheless, novel combinational treatment approaches are needed to promote neuroplasticity and motor recovery after stroke. A priority is to translate promising basic research to clinical settings and to evaluate enriched combinational therapy programs that appear to be more effective than single interventions
- What is the impact of high intensity task specific goal-directed training combined with environmental enrichment for individuals in a late phase of stroke? B. What are the subjects' experiences of the rehabilitation program? C. What are the biomarkers of successful stroke recovery? D. How does the intervention effect the subjects' walking ability on a detailed level? The study is a within-subject, repeated-measures design with pretest-posttest study, to assess outcomes after ETT. The intervention was preceded by a baseline period of usual care (UC) for 3 weeks, which also served as a control. The trial enrolled Swedish or Norwegian stroke survivors who had applied to a Swedish rehabilitation agency that provides rehabilitation services in Spain.
The physical evaluation was performed in Sweden prior to and after the intervention and 6 months after completion of the intervention / control period. In addition, a three-month follow-up in form of questionnaires was performed.
The outcome measures were:
Modified Motor Assessment Scale according to Uppsala University Hospital (M-MAS UAS) (measuring motor function), measures of walking ability, speed and endurance, dynamic and static balance, fine motor speed and dexterity in the upper limb, motor speed and gross manual dexterity, hand strength, satisfaction with life as a whole, perceived confidence in task performance, health-related quality of life and degree of depression.
Focus group interviews and individual interviews will be conducted with a subgroup of the participants (non aphasic participants) and the statements will be analyzed qualitative using content analyses as the method.
Blood samples will be taken for the analysis of biomarkers, growth factors and inflammatory markers.
Advanced analyses of gait patterns and components will be performed in a motor laboratory, including a subgroup of the participants.
In rehabilitation medicine, the general belief has been that treatment of individuals in the late phase of stroke has no functional impact. The present research program will test against this hypothesis into a clinical trial for patients at more than 6 months after stroke. The biochemical analysis of blood samples and additional preclinical studies will directly to the knowledge about possibilities to enhance brain plasticity also in later phases of stroke. The research will contribute to strengthening the evidence for a promising rehabilitation approach combining elements of focused high-intensity training with environmental enrichment for which there are strong empirical support.
- Conditions
- Stroke, Brain Diseases
- Being tested
- UC + ETT
- Keywords
- rehabilitation, recovery of function, environment
- Medical subject headings
- Stroke, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC + ETTOther
UC: A 3-week UC period, where the participants were not offered any new rehabilitation activities but were allowed to continue their regular treatment for a maximum of 3 hours per week.
ETT: The rehabilitation facilities were located in a climate that allowed and encouraged both indoor and outdoor activities. The ETT was individually tailored. Participants exercised in the same room/place as the other participants in groups of 4-9. Physical exercise was scheduled 3.5-6 hours per day, 5½ days per week for 3 weeks. The training was characterized by repetitive mass practice of gradually increasing difficulty and noncompensatory strategies, such as enforcing use of the affected side.
Beyond scheduled activities, participants were encouraged to physically engage themselves in a challenging outdoor environment.
| Study group | Role | What they receive |
|---|---|---|
| UC + ETT | Other | An enriched comprehensive task-specific therapy (ETT) program combining intensive and task-specific therapy with the sensory-motor, social, and cognitive stimulation inherent to environmental enrichment.
The intervention was preceded by a baseline period of usual care (UC) for 3 weeks, which also served as a control. Receives: Other: UC + ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Motor Assessment Scale score according to Uppsala from baseline to after intervention/control and from baseline to 6 months follow up.
Motor function
Measured: baseline, 3 weeks, 6 months
Secondary outcomes (13)
Change in Six minute walking test from baseline to after intervention/control and from baseline to 6 months follow up.
walking endurance
Measured: baseline, 3 weeks, 6 months
Change in 10 m walk test from baseline to after intervention/control and from baseline to 6 months follow up.
walking ability
Measured: baseline, 3 weeks, 6 months
Change in Box and Blocks test from baseline to after intervention/control and from baseline to 6 months follow up.
gross motor speed
Measured: baseline, 3 weeks, 6 months
Change in JAMAR from baseline to after intervention/control and from baseline to 6 months follow up.
grip strength
Measured: baseline, 3 weeks, 6 months
Change in Nine Hole Peg Test from baseline to after intervention/control and from baseline to 6 months follow up.
fine motor speed
Measured: baseline, 3 weeks, 6 months
Change in Bergs balance scale from baseline to after intervention/control and from baseline to 6 months follow up.
balance ability
Measured: baseline, 3 weeks, 6 months
Change in Life satisfaction checklist from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
satisfaction with life
Measured: baseline, 3 weeks, 3 months, 6 months
Change in Fatigue impact scale from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
effect of fatigue in daily activities
Measured: baseline, 3 weeks, 3 months, 6 months
Change in Falls Efficacy scale from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
Perceived confidence in task performance
Measured: baseline, 3 weeks, 3 months, 6 months
Change in EuroQual 5D from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
health related quality of life
Measured: baseline, 3 weeks, 3 months, 6 months
Change in Montgomery Åsberg depression rating scale from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
degree of depression
Measured: baseline, 3 weeks, 3 months, 6 months
Change in Life situation among spouses after the stroke event questionnaire from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
life situation among stroke spouses
Measured: baseline, 3 weeks, 3 months, 6 months
Change in levels of biomarkers in blood from baseline to after control/intervention and from baseline to 6 months after intervention.
Blood samples will be taken for the analysis of biomarkers, growth factors and inflammatory markers.
Measured: baseline, 3 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A within-subject, repeated-measures design with pretest-posttest evaluation was utilised to assess outcomes after ETT. The intervention was preceded by a baseline period of usual care (UC) for 3 weeks, which also served as a control
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Wallström och Sjöbloms stiftelse, Peter Erikssons minnesfond, Back to Life
- Responsible party
- Sponsor
- Investigators
- Lina Bunketorp Käll, PT, PhD, Study chair, Göteborg UniversityGeorg Kuhn, Professor, Study chair, Göteborg UniversityJean-Luc Af Geijerstam, MD, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889939
- Sponsor's protocol ID
- EEHITStroke
- Status last verified
- Oct 2018
- First submitted
- 23 Aug 2016
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vive S, Af Geijerstam JL, Kuhn HG, Bunketorp-Kall L. Enriched, Task-Specific Therapy in the Chronic Phase After Stroke: An Exploratory Study. J Neurol Phys Ther. 2020 Apr;44(2):145-155. doi: 10.1097/NPT.0000000000000309.
PubMed 32118616
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of High-intensity, Task Specific Training Combined With Environmental Enrichment for Individuals in a Late Phase After Stroke
- ClinicalTrials.gov ID
- NCT02889939
- Acronym / sponsor ID
- EEHITStroke
- Conditions
- Stroke, Brain Diseases
- Keywords
- rehabilitation, recovery of function, environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Wallström och Sjöbloms stiftelse, Peter Erikssons minnesfond, Back to Life
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We designed an explorative clinical study to assess the effectiveness of an enriched intense and task-oriented therapy program in enhancing motor recovery in patients with moderate to moderately severe hemiplegia after stroke. This enriched comprehensive task-specific therapy (ETT) program combines intensive and task-specific therapy with the sensory-motor, social, and cognitive stimulation inherent to environmental enrichment. We also investigated whether ETT improves gait, balance, upper and lower limb function, and confidence in task performance, health-related quality of life (HRQoL) and reduces fatigue and depression.
Detailed description
Background The brain has a limited ability for repair. However, in recent years it became evident that a remarkable, yet restricted ability for regeneration of neuronal connections exists, with positive implications for the rehabilitation of individuals with stroke. Several studies have shown that stroke-lesioned animals, which are exposed to a so called enriched environment (large cages, group housing of animals, equipped with toys and with possibilities for physical activity and social interactions) show signs of tissue regeneration/plasticity in the brain. Research has shown that rats exposed to this enriched environment are recovering significantly faster from stroke than rats in standard cages, despite the fact that the total tissue loss between the rats did not differ.
Recovery and improvement of motor functions and skills after stroke depend on spontaneous repair processes but also on the reorganization of neural mechanisms by stimuli and demands that are placed on the motor control system. In spite of numerous research studies showing that functional recovery after stroke is possible even many years after the stroke onset, it is unusual for stroke victims to be offered any kind of rehabilitation during later stages.
The combination of modalities in multimodal interventions is thus expected to have a synergistic effect on neuroplasticity in rehabilitation after stroke in humans. In a recent clinical trial, multimodal interventions based on rhythm and music or therapeutic horseback riding improved recovery in the late phase after stroke Nevertheless, novel combinational treatment approaches are needed to promote neuroplasticity and motor recovery after stroke. A priority is to translate promising basic research to clinical settings and to evaluate enriched combinational therapy programs that appear to be more effective than single interventions
- What is the impact of high intensity task specific goal-directed training combined with environmental enrichment for individuals in a late phase of stroke? B. What are the subjects' experiences of the rehabilitation program? C. What are the biomarkers of successful stroke recovery? D. How does the intervention effect the subjects' walking ability on a detailed level? The study is a within-subject, repeated-measures design with pretest-posttest study, to assess outcomes after ETT. The intervention was preceded by a baseline period of usual care (UC) for 3 weeks, which also served as a control. The trial enrolled Swedish or Norwegian stroke survivors who had applied to a Swedish rehabilitation agency that provides rehabilitation services in Spain.
The physical evaluation was performed in Sweden prior to and after the intervention and 6 months after completion of the intervention / control period. In addition, a three-month follow-up in form of questionnaires was performed.
The outcome measures were:
Modified Motor Assessment Scale according to Uppsala University Hospital (M-MAS UAS) (measuring motor function), measures of walking ability, speed and endurance, dynamic and static balance, fine motor speed and dexterity in the upper limb, motor speed and gross manual dexterity, hand strength, satisfaction with life as a whole, perceived confidence in task performance, health-related quality of life and degree of depression.
Focus group interviews and individual interviews will be conducted with a subgroup of the participants (non aphasic participants) and the statements will be analyzed qualitative using content analyses as the method.
Blood samples will be taken for the analysis of biomarkers, growth factors and inflammatory markers.
Advanced analyses of gait patterns and components will be performed in a motor laboratory, including a subgroup of the participants.
In rehabilitation medicine, the general belief has been that treatment of individuals in the late phase of stroke has no functional impact. The present research program will test against this hypothesis into a clinical trial for patients at more than 6 months after stroke. The biochemical analysis of blood samples and additional preclinical studies will directly to the knowledge about possibilities to enhance brain plasticity also in later phases of stroke. The research will contribute to strengthening the evidence for a promising rehabilitation approach combining elements of focused high-intensity training with environmental enrichment for which there are strong empirical support.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A within-subject, repeated-measures design with pretest-posttest evaluation was utilised to assess outcomes after ETT. The intervention was preceded by a baseline period of usual care (UC) for 3 weeks, which also served as a control
| Arm | Type | Receives |
|---|---|---|
| UC + ETT | Other | Other: UC + ETTAn enriched comprehensive task-specific therapy (ETT) program combining intensive and task-specific therapy with the sensory-motor, social, and cognitive stimulation inherent to environmental enrichment. The intervention was preceded by a baseline period of usual care (UC) for 3 weeks, which also served as a control. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least six months and maximum 10 years after the onset of stroke
- Disability grade between 2 and 4 on the Modified Rankin Scale.
- Some degree of hemiparesis, according to the primary outcome measure M-MAS UAS -99, at baseline.
- Approved by the referring / prescribing physician for intensive training
- Medically stable considering cardiovascular conditions
Key exclusion criteria (5 listed)
- Exercise-induced epilepsy.
- Injury, illness or addiction, making the individual unsuitable for participation.
- Having participated in an intense comprehensive rehabilitation program (additional to post-stroke acute- and subacute rehabilitation) at some point within the past six months.
- Scheduled for other treatment with focus on intensive training during the study.
- Use of assistive technology for sitting transfers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UC + ETTUC: A 3-week UC period, where the participants were not offered any new rehabilitation activities but were allowed to continue their regular treatment for a maximum of 3 hours per week. ETT: The rehabilitation facilities were located in a climate that allowed and encouraged both indoor and outdoor activities. The ETT was individually tailored. Participants exercised in the same room/place as the other participants in groups of 4-9. Physical exercise was scheduled 3.5-6 hours per day, 5½ days per week for 3 weeks. The training was characterized by repetitive mass practice of gradually increasing difficulty and noncompensatory strategies, such as enforcing use of the affected side. Beyond scheduled activities, participants were encouraged to physically engage themselves in a challenging outdoor environment. | Other | UC + ETT |
Primary outcome
Change in Modified Motor Assessment Scale score according to Uppsala from baseline to after intervention/control and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 6 months
Motor function
13 secondary outcomes
Change in Six minute walking test from baseline to after intervention/control and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 6 months
Change in 10 m walk test from baseline to after intervention/control and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 6 months
Change in Box and Blocks test from baseline to after intervention/control and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 6 months
Change in JAMAR from baseline to after intervention/control and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 6 months
Change in Nine Hole Peg Test from baseline to after intervention/control and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 6 months
Change in Bergs balance scale from baseline to after intervention/control and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 6 months
Change in Life satisfaction checklist from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 3 months, 6 months
Change in Fatigue impact scale from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 3 months, 6 months
Change in Falls Efficacy scale from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 3 months, 6 months
Change in EuroQual 5D from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 3 months, 6 months
Change in Montgomery Åsberg depression rating scale from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 3 months, 6 months
Change in Life situation among spouses after the stroke event questionnaire from baseline to after intervention/control, from baseline to 3 months follow up and from baseline to 6 months follow up.
Time frame: baseline, 3 weeks, 3 months, 6 months
Change in levels of biomarkers in blood from baseline to after control/intervention and from baseline to 6 months after intervention.
Time frame: baseline, 3 weeks, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Derived from this study: PubMed 32118616Vive S, Af Geijerstam JL, Kuhn HG, Bunketorp-Kall L. Enriched, Task-Specific Therapy in the Chronic Phase After Stroke: An Exploratory Study. J Neurol Phys Ther. 2020 Apr;44(2):145-155. doi: 10.1097/NPT.0000000000000309.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lina Bunketorp Käll, PT, PhD study chair
Göteborg University
Georg Kuhn, Professor study chair
Göteborg University
Jean-Luc Af Geijerstam, MD, PhD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UC + ETT in people with Stroke and Brain Diseases, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Motor Assessment Scale score according to Uppsala from baseline to after intervention/control and from baseline to 6 months follow up. (time frame: baseline, 3 weeks, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02889939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.