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Effect of the TCI Mobile app combined with lower extremity constraint-induced movement therapy on real-world lower-limb use after chronic stroke

Effect of the TCI Mobile app combined with lower extremity constraint-induced movement therapy on real-world lower-limb use after chronic stroke: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-65k2n4q
Enrollment
20
Registered
2025-11-17
Start date
2024-10-05
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic stroke with lower limb hemiparesis Stroke

Interventions

Participants (n = 20) were randomly allocated (1:1) to two groups using block randomization (block size = 4) with allocation concealment performed by an independent researcher and assessor blinding
the experimental group (n = 10) received lower extremity constraint-induced movement therapy combined with the Terapia Contensão Induzida Mobile application, consisting of 10 consecutive weekdays of s
the control group (n = 10) received the same lower extremity constraint-induced movement therapy protocol with task completion recorded using paper forms

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Universidade Federal de São Carlos
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults of both sexes aged 18 years or older with chronic stroke (=6 months post-stroke); lower limb hemiparesis; ability to walk at least 8 meters independently with or without an assistive device; and adequate cognitive function according to the Mini-Mental State Examination using education-adjusted cutoff scores

Exclusion criteria

Exclusion criteria: Severe visual impairment; other neurological conditions unrelated to stroke; orthopedic conditions unrelated to stroke that could interfere with the intervention or assessments; respiratory disorders that could interfere with performance

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: A greater improvement in affected lower extremity use in daily life is expected in the Terapia Contensao Induzida Mobile group compared to the control group measured by the Lower Extremity Motor Activity Log Functional Ability subscale at 30 days post intervention;Observed outcome 1: A significant group by time interaction was observed for the Lower Extremity Motor Activity Log Functional Ability subscale favoring the Terapia Contensao Induzida Mobile group at 30 days post intervention with a between group difference in change of 1.23 points 95 percent confidence interval 0.12 to 2.34 p equals 0.03

Secondary

MeasureTime frame
Expected outcome 2: Improvements are expected in lower extremity use motor function mobility and walking performance measured by the Lower Extremity Motor Activity Log total score and subscales Lower Extremity Motor Function Test Life Space Assessment Timed Up and Go Six Minute Walk Test and Ten Meter Walk Test;Observed outcome 2: No significant group by time interactions were observed for secondary outcomes adherence was higher in the Terapia Contensao Induzida Mobile group compared to the control group

Countries

BR

Contacts

Public ContactNatalia Pereira

Universidade Federal de São Carlos

nataliaduartepereira@ufscar.br+55-16-3351-9685

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026