Arm-hand Boost Program During Inpatient Rehabilitation After Stroke

Jessa Hospital

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Arm-hand BOOST program; Behavioral: Control program

Study type: Interventional

Funder types: Other

Identifiers

NCT04584177

Study 19.27

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Arm-hand BOOST + Control

Experimental group

Description:

First 4 weeks arm-hand boost program, afterwards, 4 weeks of control program

Treatment:

Behavioral: Arm-hand BOOST program

Behavioral: Control program

Control + Arm-hand BOOST

Experimental group

Description:

First 4 weeks control program, afterwards 4 weeks arm-hand boost program

Treatment:

Behavioral: Arm-hand BOOST program

Behavioral: Control program