High-intensity Training in an Enriched Environment in Late Phase After Stroke
Condition: Stroke; Brain Diseases
MeSH terms: Stroke; Brain Diseases
Study type: Interventional

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. 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

      A. 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.
    

Intervention name(s): UC + ETT
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: rehabilitation; recovery of function; environment