High-intensity Training in an Enriched Environment in Late Phase After Stroke

Recruiting

Phase 2 Results N/A

Trial Description

The aim of this project is to investigate whether it is possible to improve the functioning and activity level for individuals more than 6 months after stroke by partaking in a rehabilitation program consisting of high-intensity task-specific, goal-directed training in an enriched environment.

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. High quality randomized controlled trials in this field are needed as well as pre-clinical studies of the exercise-induced mechanisms in order to establish alternative therapeutic approach for individuals with a history of stroke.
No previous study has evaluated the effect of high-intensity, task-specific, goal-directed training combined with enriched environment, for individuals in a late phase of stroke. The aim of this project is to investigate whether it is possible to improve the functioning and activity level for individuals more than 6 months after stroke by partaking in a rehabilitation program consisting of high-intensity task-specific, goal-directed training in an enriched environment. The specific research questions are:
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 single blinded randomized controlled trial with cross-over design, in which approximately 36 individuals in the late phase of stroke will be included. Participants will be randomized to either the intervention or control group. The intervention will take place at a rehabilitation facility in the south of Spain. The main reason for choosing this location over a rehab facility in Sweden is to provide an environment with stable condition for outdoor activities and sensory stimulation.
The control group (being in their home environment) will not be not offered any kind of organized intervention but will be allowed to continue with conventional treatment, if engaged in for example physiotherapeutic training, occupational or speech therapy for a maximum of 3 hours/week. After the control period, the control group will partake in the rehabilitation program.
The physical evaluation is 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 will be performed.
The primary outcome measure is:
Modified Motor Assessment Scale according to Uppsala University Hospital (M-MAS UAS) (measuring motor function) Secondary outcome measures are measuring 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 controlled 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

Interventions

  • Control Device
    Intervention Desc: Control subjects are evaluated before and after a three-week long period referred to as the "control period". During this control period (taking place in participants' home environment) the control subjects are not offered any type of organized intervention but are allowed to continue with conventional treatment, that may not exceed 3 hours a week, while taking part in the trial. The control subjects are asked not to undertake any other rehabilitation during the control period, but only to continue ongoing training, if any according the above mentioned restrictions. Directly after the control period, the participants will be crossing over and receive the intervention.
    ARM 1: Kind: Experimental
    Label: Control
    Description: Control subjects are evaluated before and after a three-week long period referred to as the "control period". Directly after the control period, the participants will be crossing over and receive the intervention.
  • Training + Enriched environment Other
    Intervention Desc: A rehabilitation program consisting of high-intensity training in an enriched environment: The intervention takes take place at a rehabilitation facilities located in Spain. The program includes training of impaired function in the affected arm and hand, walking and balance training, as well as lectures designed to widen knowledge about stroke and its effects on the participants and related parties. The training is task-specific, goal-directed, intensive, including mass practice and gradually with increased difficulty. The environment at the rehabilitation facilities is physically challenging and participants are asked to challenge themselves physically.
    ARM 1: Kind: Experimental
    Label: Training + enriched environment
    Description: A rehabilitation program consisting of high-intensity training in an enriched environment.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Modified Motor Assessment Scale score according to Uppsala from baseline to after intervention/control and from baseline to 6 months follow up. baseline, 3 weeks, 6 months No
Secondary Change in Six minute walking test from baseline to after intervention/control and from baseline to 6 months follow up. baseline, 3 weeks, 6 months No
Secondary Change in 10 m walk test from baseline to after intervention/control and from baseline to 6 months follow up. baseline, 3 weeks, 6 months No
Secondary Change in Box and Blocks test from baseline to after intervention/control and from baseline to 6 months follow up. baseline, 3 weeks, 6 months No
Secondary Change in JAMAR from baseline to after intervention/control and from baseline to 6 months follow up. baseline, 3 weeks, 6 months No
Secondary Change in Nine Hole Peg Test from baseline to after intervention/control and from baseline to 6 months follow up. baseline, 3 weeks, 6 months No
Secondary Change in Bergs balance scale from baseline to after intervention/control and from baseline to 6 months follow up. baseline, 3 weeks, 6 months No
Secondary 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. baseline, 3 weeks, 3 months, 6 months No
Secondary 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. baseline, 3 weeks, 3 months, 6 months No
Secondary 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. baseline, 3 weeks, 3 months, 6 months No
Secondary 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. baseline, 3 weeks, 3 months, 6 months No
Secondary 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. baseline, 3 weeks, 3 months, 6 months No
Secondary 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. baseline, 3 weeks, 3 months, 6 months No
Secondary Change in levels of biomarkers in blood from baseline to after control/intervention and from baseline to 6 months after intervention. baseline, 3 weeks, 6 months No

Sponsors