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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Sweden1 site
  • Sahlgrenska University Hospital

    Gothenburg

Other trials in Sweden

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

  1. 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.

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 groups in NCT02889939
Study groupRoleWhat they receive
UC + ETTOtherAn 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted7 Sep 2016 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2015
  4. Study completionAug 2017

Resources

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)
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

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.

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