Effects of Combined vs. Sequential Attentional Focus Instructions on Upper Extremity Function in Subacute Stroke

NCT07289308 | Recruiting DMC

• 1 other identifier: EKPP25ST
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a leading cause of long-term disability, and upper extremity impairments-affecting about 80% of survivors-limit functional reach, grasp, and manipulation more severely than lower limb deficits. Despite partial recovery of walking ability, meaningful functional use of the paretic arm remains limited. Conventional rehabilitation often lacks sufficient intensity, task specificity, and motor learning principles, highlighting the need for more effective approaches. The subacute phase of stroke (up to 6 months post-onset) represents a period of heightened neuroplasticity and strong rehabilitation potential. During this time, integrating cognitive and motor training-such as attentional focus strategies-has gained attention. External focus enhances movement efficiency through motor automaticity, whereas internal focus supports early motor control. Evidence suggests that combining these strategies may optimize recovery, yet their relative effectiveness in stroke rehabilitation remains unclear. Two main instructional approaches exist: combined attentional focus (internal and external cues delivered within the same session) and sequential attentional focus (internal focus first, followed by external focus as control improves). While both show therapeutic promise, comparative data in stroke populations are lacking. This study aims to compare combined versus sequential attentional focus instructions in improving upper extremity function in subacute stroke. We hypothesize that a combined approach-starting with internal focus early, then integrating external focus-will yield superior motor improvements.

Conditions

Upper Extremity Dysfunction; Cue, Threat; Stroke

Keywords

Wolf Motor Function Test; Motor Learning; Functional Recovery; Fugl-Meyer Assessment; Action Research Arm Test

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Assessment- Upper Extremity Subscore

  The Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) is a validated scale used to evaluate motor control, coordination, and functional performance of the affected arm in stroke patients. Scores range from 0 to 66, with higher scores indicating better motor function.

  baseline, four weeks after the baseline

Secondary Outcomes (3)

• Fugl-Meyer Assessment-Total Score

  baseline, four weeks after the baseline

• Action Research Arm Test

  baseline, four weeks after the baseline

• Wolf Motor Function Test

  baseline, four weeks after the baseline

Study Arms (3)

Combined Focus of Attention Group (CFAG)

EXPERIMENTAL

Participants in the Combined Focus of Attention Group will receive a standardized rehabilitation program plus a task-specific upper extremity training session with combined internal and external attentional focus instructions. During each task (e.g., reaching, grasping, holding objects), participants will be instructed to focus simultaneously on body movements (internal focus, e.g., "feel your shoulder moving as you extend your arm") and movement effects on the environment (external focus, e.g., "focus on the target and guide your hand to touch it"). Sessions are conducted five times per week in the clinic and twice per week at home, each lasting 60 minutes (45 minutes standard rehab + 15 minutes attentional focus training), over four weeks.

Other: Combined Focus of Attention Instructions; Other: standart rehabilitation program

Sequential Focus of Attention Group (SFAG)

EXPERIMENTAL

Participants in the Sequential Focus of Attention Group will receive a standardized rehabilitation program plus a task-specific upper extremity training session with sequential attentional focus instructions. Internal focus cues (e.g., "feel your shoulder moving as you extend your arm") are provided during the first two weeks to enhance basic motor control, followed by external focus cues (e.g., "focus on the target and guide your hand to touch it") during the next two weeks to improve movement efficiency and functional performance. Sessions are conducted five times per week in the clinic and twice per week at home, each lasting 60 minutes (45 minutes standard rehab + 15 minutes attentional focus training), over four weeks.

Other: Sequential Focus of Attention Instructions; Other: standart rehabilitation program

Control Group

ACTIVE COMPARATOR

Participants in the Control Group will receive the standardized rehabilitation program only, without any specific attentional focus instructions. The program includes task-oriented upper extremity exercises targeting range of motion, motor control, coordination, and functional performance. Sessions are conducted five times per week in the clinic and twice per week at home, each lasting 60 minutes, over four weeks.

Other: standart rehabilitation program

Interventions

Combined Focus of Attention Instructions OTHER

Participants perform task-specific upper extremity exercises while receiving simultaneous internal and external attentional focus cues, directing attention both to body movements (internal focus) and movement effects on the environment (external focus). This combined approach aims to enhance motor control, movement efficiency, and functional performance.

Combined Focus of Attention Group (CFAG)

Sequential Focus of Attention Instructions OTHER

Participants perform task-specific upper extremity exercises with internal attentional focus cues during the first two weeks (focusing on body movements, e.g., "feel your shoulder moving"), followed by external attentional focus cues during the next two weeks (focusing on movement effects, e.g., "focus on the target and guide your hand to touch it").

Sequential Focus of Attention Group (SFAG)

standart rehabilitation program OTHER

All participants receive a standardized, evidence-based rehabilitation program targeting upper extremity range of motion, motor control, coordination, and functional performance. Sessions are conducted five times per week in the clinic and twice per week at home, each lasting 45 minutes, over four weeks.

Combined Focus of Attention Group (CFAG); Control Group; Sequential Focus of Attention Group (SFAG)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-80 years at enrollment (Kwakkel et al., 1996; Coupar et al., 2012).
• Stroke diagnosed by a neurologist between 1 week and 6 months before enrollment (Langhorne et al., 2020; Bernhardt et al., 2017).
• Medically stable, as confirmed by a neurologist, with controlled and non-fluctuating vital signs (Stinear et al., 2020; Powers et al., 2019; Winstein et al., 2016).
• Sufficient cognitive function to follow instructions, sustain attention, and actively participate in rehabilitation, as judged by the treating therapist (Stinear et al., 2020; Boyd et al., 2018).
• Brunnstrom stage 2-5 in the affected upper limb (Brunnstrom, 1970; Langhorne et al., 2020).
• Individuals with a Modified Ashworth Scale (MAS) score \<3: Participants were required to have a MAS score of less than 3 in both the upper and lower extremities to ensure that spasticity remained at a manageable level and to allow safe participation in upper-limb motor rehabilitation (Pandyan et al., 2005; Li \& Francisco, 2015; Ada et al., 2020).
• Preserved corticospinal tract integrity, confirmed by a positive Motor Evoked Potential (MEP) response (Stinear et al., 2017; Byblow et al., 2015; Stinear et al., 2020).
• Moderate to severe upper-extremity motor impairment, determined by Fugl-Meyer Assessment (FMA) scores of 0-47 (0-19 severe, 20-47 moderate) (Fugl-Meyer et al., 1975).

You may not qualify if:

• Spasticity level: Individuals with a Modified Ashworth Scale (MAS) score ≥3 in either the upper or lower extremities were excluded, as marked hypertonicity and severe spastic contractions could negatively affect proximal stabilization and movement strategies, thereby interfering with upper-limb task performance (Pandyan et al., 2005).
• Fractures: Participants with a current or recent fracture on the affected side of the body were excluded from the study.
• Botulinum toxin injections: Individuals who had received Botulinum Toxin (Botox) injections within the previous three months were excluded due to the potential effects of the intervention on muscle tone and motor performance.
• Communication disorders: Participants with motor or global aphasia, or other communication impairments that could interfere with understanding instructions or performing the required tasks, were excluded.
• Concurrent rehabilitation: Individuals who were concurrently receiving rehabilitation treatment at another facility were excluded to prevent potential confounding effects from parallel interventions (Winstein et al., 2016).
• Non-adherence to treatment sessions: Participants who failed to attend all required treatment sessions were excluded to ensure consistency and fidelity of the intervention protocol (Winstein et al., 2016).

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Neur-On Clinic, İstinye University, Bahcesehir Liv Hospital Stroke Center

Istanbul, 34517, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Emirhan Kocer, PT

  Bahcesehir University, Graduate Education Institute

  PRINCIPAL INVESTIGATOR

• Pelin Pisirici, PT, PhD

  Bahcesehir University, Faculty of Health Sciences

  STUDY CHAIR

Central Study Contacts

Pelin Pisirici, PT, PhD

CONTACT

05055016076; pelin.pisirici@bau.edu.tr

Emirhan Kocer, PT

CONTACT

+90 539 637 45 49; emirhan.kocer@bahcesehir.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation to ensure unbiased measurement of upper extremity function. Interventionists delivering the rehabilitation sessions are not blinded due to the need to provide group-specific attentional focus instructions. Participants are aware of the type of instructions they receive, but they are not informed of the study hypothesis or comparative group details. This single-assessor blinded design minimizes bias while maintaining intervention fidelity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PT, PhD

Model Details: This is a prospective, assessor-blinded, randomized controlled parallel-group study. Subacute stroke patients will be randomly assigned to one of three groups: Combined Focus of Attention Group (CFAG), Sequential Focus of Attention Group (SFAG), or Control Group (CG). Each participant will receive a standardized rehabilitation program, with the experimental groups additionally receiving task-specific upper extremity training with group-specific attentional focus instructions. Outcomes will be assessed at baseline and after four weeks by a blinded physiotherapist to evaluate the effects of combined versus sequential attentional focus instructions on upper extremity motor function.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: January 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

TU (1)