Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584177
• Other study ID #: Study 19.27
• Status: Completed
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: November 3, 2020

Study information

• Verified date: August 2020
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 3, 2020
• Est. primary completion date: November 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Arm-hand BOOST program
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
A dose-matched program of strengthening exercises for the lower limbs and general reconditioning

Locations

Country	Name	City	State
Belgium	Jessa Hospital, Campus Sint-Ursula	Herk-de-Stad

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Fugl-Meyer Assessment-Upper Extremity at 4 weeks	UL assessment - Function	Between baseline and first 4 weeks of study
Primary	Change from Fugl-Meyer Assessment-Upper Extremity at 8 weeks	UL assessment - Function	Between baseline and end of study (=8 weeks)
Primary	Change from Action Research Arm Test at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Primary	Change from Action Research Arm Test at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)
Secondary	Change from Jebsen Taylor hand function test at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Secondary	Change from Jebsen Taylor hand function test at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)
Secondary	Change from Rivermead Motor Assessment Arm function at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Secondary	Change from Rivermead Motor Assessment Arm function at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)
Secondary	Change from Stroke upper limb capacity scale (SULCS) at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Secondary	Change from Stroke upper limb capacity scale (SULCS) at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)
Secondary	Change from Box & Block test at 4 weeks	UL Assessment - Activities	Between baseline and first 4 weeks of study
Secondary	Change from Box & Block test at 8 weeks	UL Assessment - Activities	Between baseline and end of study (=8 weeks)