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Completed

NCT Number: NCT04584177

Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

A pilot cross-over RCT including participants with sub-acute stroke is conducted in an inpatient rehabilitation setting. The experimental group (EG) receives an arm-hand boost program on top of their usual care program. The control group (CG) receives a dose-matched program of strengthening exercises for the lower limbs and general reconditioning. After 4 weeks, a cross-over is performed. Before, after 4 weeks and after 8 weeks of additional therapy, different clinical outcome measures for the upper limb are administered.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital, Campus Sint-Ursula

Herk-de-Stad, 3540, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first stroke, as defined by WHO,
  • minimal stay of 4 weeks in inpatient setting at study start
  • minimally 18 years old
  • being able to sit independently (trunk control test, item 3 = 25),
  • motor impairment in the upper limb (Fugl-Meyer assessment, stage 2 (synergies): 8-17p, or stage 2: <8p combined witht stage 5 (hand): >6p
  • sufficient cooperation to perform intervention and evaluations

Exclusion criteria

  • musculoskeletal and/or other neurological impairments with permanent damage that may hinder the study
  • subdural hematoma, tumor, encephalitis, trauma, or other that lead to similar symptoms as stroke
  • severe communication, cognitive or language impairments that hinder the investigations
  • no written informed consent

Treatment and study plan

Arm-hand BOOST program

Behavioral

The arm-hand boost program is provided 1 hour/day, 5x/week for 4 weeks, on top of their usual care program. The focus of the boost program is on scapula-setting, core-stability when reaching, movements with 30-60° flexion/abduction in shoulder, fine manipulation and integration in complex ADL tasks. Additionally, patients exercise 1 hour per week using the Armeo Power (Hocoma). Therefore, the additional arm-hand boost program consists of 24 one-hour sessions, provided over four weeks.

Control program

Behavioral

A dose-matched program of strengthening exercises for the lower limbs and general reconditioning

Primary outcomes

  1. Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks

    Time frame: Between baseline and first 4 weeks of study

    UL assessment - Function

  2. Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks

    Time frame: Between baseline and end of study (=8 weeks)

    UL assessment - Function

  3. Change from Action Research Arm Test at 4 weeks

    Time frame: Between baseline and first 4 weeks of study

    UL Assessment - Activities

  4. Change from Action Research Arm Test at 8 weeks

    Time frame: Between baseline and end of study (=8 weeks)

    UL Assessment - Activities

Secondary outcomes

  1. Change from Jebsen Taylor hand function test at 4 weeks

    Time frame: Between baseline and first 4 weeks of study

    UL Assessment - Activities

  2. Change from Jebsen Taylor hand function test at 8 weeks

    Time frame: Between baseline and end of study (=8 weeks)

    UL Assessment - Activities

  3. Change from Rivermead Motor Assessment Arm function at 4 weeks

    Time frame: Between baseline and first 4 weeks of study

    UL Assessment - Activities

  4. Change from Rivermead Motor Assessment Arm function at 8 weeks

    Time frame: Between baseline and end of study (=8 weeks)

    UL Assessment - Activities

  5. Change from Stroke upper limb capacity scale (SULCS) at 4 weeks

    Time frame: Between baseline and first 4 weeks of study

    UL Assessment - Activities

  6. Change from Stroke upper limb capacity scale (SULCS) at 8 weeks

    Time frame: Between baseline and end of study (=8 weeks)

    UL Assessment - Activities

  7. Change from Box & Block test at 4 weeks

    Time frame: Between baseline and first 4 weeks of study

    UL Assessment - Activities

  8. Change from Box & Block test at 8 weeks

    Time frame: Between baseline and end of study (=8 weeks)

    UL Assessment - Activities

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

Arm-hand Boost Program During Inpatient Rehabilitation After Stroke: Pilot Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 12, 2020
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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