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

NCT02889939 | Completed

• 1 other identifier: EEHITStroke
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Brain Diseases

Keywords

rehabilitation; recovery of function; environment

Outcome Measures

Primary Outcomes (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

  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.

  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.

  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.

  baseline, 3 weeks, 6 months

• Change in JAMAR from baseline to after intervention/control and from baseline to 6 months follow up.

  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.

  baseline, 3 weeks, 6 months

Study Arms (1)

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.

Other: UC + ETT

Interventions

UC + ETT OTHER

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.

UC + ETT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead
• Wallström och Sjöbloms stiftelse: collaborator
• Peter Erikssons minnesfond: collaborator
• Back to Life: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (1)

• 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.

  PMID: 32118616 DERIVED

MeSH Terms

Conditions

Stroke; Brain Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lina Bunketorp Käll, PT, PhD

  Göteborg University

  STUDY CHAIR

• Georg Kuhn, Professor

  Göteborg University

  STUDY CHAIR

• Jean-Luc Af Geijerstam, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2017
• Last Updated: November 2, 2018

Record last verified: 2018-10

Locations

SE (1)