# A custom-made sling to achieve personal goals in shoulder pain or subluxation in the subacute stroke phase: a pilot study

Emmeline Montané, Magali Pradié, Ines Bigarre, Claire Lebely, Alizée Lelièvre, Camille Cormier, Jacqueline Butterworth, Benoît Lepage, Philippe Marque, Xavier de Boissezon, et al.

► To cite this version:

Emmeline Montané, Magali Pradié, Ines Bigarre, Claire Lebely, Alizée Lelièvre, et al. A custom-made sling to achieve personal goals in shoulder pain or subluxation in the subacute stroke phase: a pilot study. Annals of Physical and Rehabilitation Medicine, 2025, 68 (7), pp.102014. 10.1016/j.rehab.2025.102014. hal-05524856

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Research letter

# A custom-made sling to achieve personal goals in shoulder pain or subluxation in the subacute stroke phase: a pilot study

<figure><img src="image_2.png" /></figure>

Emmeline Montané<sup>a,b,#</sup>, Magali Pradié<sup>a,#</sup>, Inès Bigarre<sup>a</sup>, Claire Lebely<sup>a</sup>, Alizée Lelièvre<sup>a</sup>, Camille Cormier<sup>a,c</sup>, Jacqueline Butterworth<sup>d</sup>, Benoît Lepage<sup>e</sup>, Philippe Marque<sup>a,b</sup>, Xavier de Boissezon<sup>a,b</sup>, Evelyne Castel-Lacanal<sup>a,b,*</sup>

ARTICLE INFO

Keywords:

Stroke

Hemiplegia

Shoulder orthosis

Pain

Subluxation

Goal attainment scaling

A B S T R A C T

**Background:** The efficacy of the different shoulder orthoses available to prevent hemiplegic shoulder complications still remains debatable.

**Objectives:** To evaluate how wearing a custom-made (CM) shoulder sling affected personal goals and complications among hemiplegic stroke patients undergoing realworld rehabilitation.

**Methods:** A prospective, single-center, non-randomized, pilot study on patients having a stroke within the last 6 months with hemiplegic shoulder pain/subluxation >5 mm. The primary outcome was achievement in three personal goals according to Goal Attainment Scaling one month after (week 5) compared to before (day 7) sling wearing.

**Results:** Twenty-two patients were included: 60 % male, 56.4 ± 12.1 years old. ≥1 goal was achieved by 90.5 % of patients after sling wearing (week 5) versus 36 % of patients before. VAS pain score (-1.3 ± 2.3; *p* = 0.01) and subluxation distance (-0.41±0.42 cm; *p* = 0.0001) were reduced at week 5. Both the Chedoke Arm and Hand Activity Inventory score (+9.0 ± 13.1; *p* = 0.0003) and Fugl-Meyer upper-extremity score (+9.5 ± 9.5; *p* = 0.00002) were improved after sling wearing.

**Conclusion:** We observed improvements in patient-desired outcomes, complications, and upper-limb functional recovery after CM sling wearing for 1-month.

**Trial registration:** NCT04028999.

Dear Editor,

Hemiplegic shoulder pain (HSP) is a common post-stroke complication with incidence rates varying according to population and time since stroke [1]. Symptoms can occur in 17 % of individuals within one week after a stroke [2], rising to approximately 33 % within 6 months [3]. Shoulder subluxation, caused by the gravitational displacement of the humerus, is a predominant cause of HSP [4]. This subluxation stretches the glenohumeral capsule, resulting in inferior displacement, making arm elevation difficult and hindering upper-limb activity [5]. Although

limiting arm movement can reduce pain during the post-stroke recovery phase, free movement is essential to promote functional recovery [6].

The management of refractory painful shoulders by conservative treatments or surgery remains a challenge [7]. Subluxation can be treated earlier or prevented by using shoulder orthoses (also called slings) [8]. Slings are removable devices that support the weight of the affected arm to limit subluxation and soft tissue stretching. Some slings can restrict the free movement required for recovery via immobilizing the upper limb, whereas others (more effective) allow for free movement while supporting the distal upper limb. However, despite improvements in subluxation while in situ, it remains unknown whether sling-wearing

**Abbreviations:** BDAE, Boston Diagnostic Aphasia Examination; CAHAI, Chedoke Arm and Hand Activity Inventory; CM, custom-made; ESAT, évaluation de satisfaction envers une aide 2 technique; GAS, Goal attainment scaling; HSP, hemiplegic shoulder pain; SMART, specific, measurable, achievable, relevant, and time-specific criteria; VAS, visual analog scale

*Corresponding author.

E-mail address: castel-lacanal.e@chu-toulouse.fr (E. Castel-Lacanal).

* These authors contributed equally to this work

<figure><img src="image_3.png" /></figure>

<footnote><sup>a</sup> Department of Physical and Rehabilitation Medicine, Bâtiment Raymonde Fournet, Toulouse University Hospital, Place du Dr Baylac, 31059 Toulouse Cedex 9, France</footnote>

<footnote><sup>b</sup> ToNIC (Toulouse NeuroImaging Center), Inserm, UMR 1214 University Toulouse III, Pavillon Baudot, Toulouse 31300, France</footnote>

<footnote><sup>c</sup> Department of Physiological Explorations, Rangueil Hospital, Toulouse University Hospital, 1 avenue du Pr Jean Poulhès, Toulouse 31400, France</footnote>

<footnote><sup>d</sup> ITAC (Institute of Advanced and Surgical Technologies), Pierre-Paul Riquet Hospital, Toulouse University Hospital, Place du Dr Baylac, 31059 Toulouse Cedex 9, France</footnote>

<footnote><sup>e</sup> Department of Public Health and Epidemiology, Toulouse University Hospital, 37 allées Jules-Guesde, Toulouse 31000, France</footnote>
can reverse subluxation and prevent HSP [9]. Additionally, no official guidelines exist on which positioning-assistive device to use for the prevention or treatment of hemiplegic shoulder complications according to the specific clinical context and desired outcomes.

Occupational therapists from the Department of Physical and Rehabilitation Medicine (Toulouse University Hospital, France), in collaboration with an orthoprothesist technician, reached a consensus on the design of a novel custom-made (CM) shoulder sling for individuals with hemiplegic stroke (Supplementary Methods). The CM sling is capable of fitting all body morphologies while allowing for free use of the upper limb with distal support (Fig. 1A-C).

We performed a non-randomized, prospective, interventional, pilot, pragmatic study on participants treated with the CM sling for shoulder subluxation and/or HSP while hospitalized for routine inpatient or outpatient stroke rehabilitation. Participant inclusion was from July 3, 2019 until December 31, 2022. Approval was granted from the IRB of Toulouse University Hospital (ClinicalTrials.gov reference NCT04028999), and informed consent was obtained from all participants. Procedures were performed in accordance with institutional standards and the Helsinki Declaration. Rehabilitation care was 2 h each weekday.

The primary objective was to assess the impact of wearing the CM sling on goals related to the daily activities of post-stroke individuals. For this purpose, Goal Attainment Scaling (GAS) methodology was used to determine desired outcome-related goals, and then examine their changes in achievement after sling-wearing. This study is the first to report the use of GAS methodology to evaluate sling effectiveness in real-world rehabilitation. Secondary objectives evaluated how sling-wearing affected shoulder pain, subluxation, and upper-limb functional recovery.

Inclusion criteria were adult participants: (1) having a first stroke within the last 6 months causing hemiparesis or hemiplegia, (2) having a Boston Diagnostic Aphasia Examination (BDAE) score >3, and (3) indicated a shoulder orthosis for the management of HSP (pain visual analog scale, VAS, ≥4) and/or subluxation ≥0.5 cm. Subluxation was determined by palpation between the acromion and the humeral head, and

tape measured in the standing position without affected arm support. Exclusion criteria included: stroke recurrence, first stroke >6 months ago, any history of shoulder weakness/prior sling-wearing, shoulder joint disease, participants with lymphedema/upper-limb venous thrombosis, neoprene allergy, and severe cognitive impairment (mini-mental state examination score <15).

On day 0 (visit 1), patients were measured by the orthoprothesist for the making of the CM sling (Supplementary Methods). Clinical assessments were also performed, including: (1) determination of the 3 most meaningful individualized goals with realistic score definitions through collaborative participant-occupational therapist agreement; (2) average pain intensity over the previous 24 h using a 0 cm (no pain) to 10 cm (worst imaginable pain) VAS; (3) subluxation distance (cm); (4) total upper-extremity Fugl-Meyer score out of 66 (A + B + C + D); and (5) Chedoke Arm and Hand Activity Inventory (CAHAI)-13 score (total 94).

On day 7 (visit 2), participants had a “pre-CM sling” evaluation followed by training on CM sling use. Participants were fitted with their CM sling for continuous use on the same day. On day 14 (visit 3), a first “with-CM sling” evaluation was performed. On week 5 (visit 4), participants had an end-of-study “with-CM sling” evaluation after 4 weeks of sling-wearing. Table S1 summarizes the clinical examinations performed at each visit.

GAS scores were recorded on day 7 (before sling) and week 5 (after sling) by the same non-blinded occupational therapist who set goals at day 0. GAS scores were rated on a 5-point Likert scale: 0 indicating the expected level of achievement for the scheduled rehabilitation; -2, a far lower achievement than expected (same as baseline at day 7); -1, lower achievement than expected; +1, higher achievement than expected; and, +2, indicating a far higher achievement than expected [10]. Goals with GAS scores ≥0 were classed as achieved, and goals with GAS scores <0 were classed as failed. Statistical analyses are detailed in Table 2 footnotes and the Supplementary Methods.

A total of 25 participants were initially recruited; 22 of them were included in the final analyses (Fig. 1D). At inclusion, the mean age was 56.4 (SD, 12.1; range 31.1–78.8) years, 60 % of participants were male, and the mean body mass index was 25.5 (4) [18.8–35.6] kg/m². The

<figure><img src="image_4.png" /><figcaption>**Fig. 1.** The custom-made shoulder sling used in the pilot pragmatic before-and-after study. (A) The 2 parts of the non-CE-marked, Class I-registered, custom-made sling made of neoprene. (B) The first part consists of a shoulder brace with an elastic strap passing under the contralateral axilla to connect the sternal and scapular parts in an innovative dorsal-side Y-configuration. Note that the tightness of this part can be adjusted accordingly across any body shape without creasing to optimally distribute fitted support from between the shoulder top to 2 cm above the elbow. (C) The second part is a velcro-fitted glove connected to the shoulder brace by an adjustable elastic strap to provide distal support. (D) The study flowchart.</figcaption></figure>
<caption>**Table 1**</caption>

Number of goals achieved per participant before (day 7) and 1 month (week 5) after wearing a custom-made sling.

<table><thead><tr><th>Number of goals achieved (GAS score ≥0), n (%)</th><th>Before sling</th><th>After sling</th></tr></thead><tbody><tr><td>0</td><td>16 (64%)</td><td>2 (10%)</td></tr><tr><td>1</td><td>8 (32%)</td><td>6 (29%)</td></tr><tr><td>2</td><td>0</td><td>7 (33%)</td></tr><tr><td>3</td><td>1 (4%)</td><td>6 (29%)</td></tr><tr><td>Participants analyzed (n)</td><td>25</td><td>21<sup>a</sup></td></tr></tbody></table>

GAS: Goal Attainment Scaling

a Missing data for one included participant

mean delay since stroke was 58.1 (26.8) [28–151] days. Ischemic stroke was predominant (n = 16/25, 64 %), followed by hemorrhagic stroke (n = 7/25, 28 %), and ischemic stroke with intracerebral hematoma (n = 2/25, 8 %). The mean BDAE score was 4.6 (0.5) [4–5].

A total of 75 GAS goals (3 per participant) were set on day 0. The 3 goals were labeled from A (highest priority) to C, and refer to separate objectives (Table S2). The most common pre-defined goal categories were: upper-limb functional performance (n = 23/75, 31 % of goals; ≥1 goal among 76 % of participants), upper-limb use in daily living (n = 20/75, 27 % of goals; ≥1 goal among 72 % of participants), pain (n = 13/75, 17 % of goals; among 52 % of participants), subluxation (n = 10/75, 13 % of goals; among 40 % of participants), and spasticity (n = 9/75, 12 % of goals; among 36 % of participants).

The number of participants achieving at least one goal increased from 36 % before sling-wearing (day 7) to 91 % after sling-wearing (week 5) (Table 1). More precisely, while the proportion of participants achieving one goal remained similar before (32 %) vs after (29 %) sling-wearing, a shift was observed toward more participants achieving 2 (0 % vs 33 %) or 3 (4 % vs 29 %) goals after sling-wearing. Accordingly, goal achievement rates and median GAS scores significantly improved after sling-wearing (Tables S3 and S4, Figure S1). Finally, we found no significant differences in achievement rate according to goal category distribution (separate goals or all goals combined), both before (day 7; data not shown) and after sling-wearing (week 5; Table S5). Hence, goal achievement was independent of the different goal categories.

The mean GAS pain score was significantly reduced after 1 month of sling-wearing, compared to day 0 and day 7. These reductions were

more pronounced among participants with a GAS pain score >0 at inclusion (Table 2). After sling-wearing, we found pain improvement (≥2-VAS score reduction) in 59 % (13/22) of participants, pain resolution in 14 % (3/22), and pain deterioration (≥1.5-VAS score increase) in 18 % (4/22) of participants. It is noteworthy that 55 % of participants who had set a pain-related goal achieved it after 1 month (Table S5). Mean subluxation distance significantly decreased after 1 month compared to both day 0 and day 7.

Mean total upper-extremity Fugl-Meyer score ranged substantially between participants (0–45) at day 0 but significantly improved after 1 month of sling-wearing (Table 2). Mean CAHAI score also significantly improved after 1 month of sling-wearing compared to day 0 and day 7 (Table 2). Upper-limb spasticity (Tardieu scale) was moderate on day 0 and did not significantly change by week 5 (Supplementary Results).

All participants were complying with sling-wearing instructions at visits 3 and 4. Satisfaction was assessed via the Quebec User Evaluation of Satisfaction with Assistive Technology version 2.0 questionnaire (ESAT 2.0 in French) [11]. This 12-item questionnaire covers device-related technical (dimensions, weight, ease of adjustment, security, durability, ease of use, comfort, and effectiveness for users’ needs) and service (professional service, follow-up services, repairs/servicing, service delivery) domains rated by a 5-point Likert satisfaction scale (5 for very satisfied). We report mean scores of 4.3 (SD, 0.5) for the technical and 4.4 (SD, 0.7) for the service delivery subdomains. Five participants (5/22, 23 %) experienced one adverse event each: 2 cases of falls, 1 case of wrist tendinitis on the affected side, 1 case of upper-limb algodystrophy on the affected side, and 1 case of hand edema on the affected side.

Overall, our cohort included participants with known clinical risk factors for subacute phase shoulder subluxation, namely moderate-to-severe proximal upper-limb motor deficits [12] (Table 2). After 1 month of CM sling-wearing during real-world stroke rehabilitation, we observed improved outcomes related to daily living, including reduced pain, with no deterioration in subluxation or upper-limb functional recovery. In addition, through our GAS approach, we were able to examine the individual expectations from CM sling-wearing, followed by how these expectations were met in the participants’ daily lives.

Recent studies demonstrate how GAS methodology in rehabilitation evaluation is on the rise [13–15], highlighting how GAS can be adapted to various contexts in rehabilitation. However, GAS methodology has some caveats; for example, the GAS setting team must generate clinically

<caption>**Table 2**</caption>

Changes in secondary outcome measures between before and after custom-made sling-wearing.

<table><thead><tr><th></th><th>Day 0,<br>(Inclusion)</th><th>Day 7,<br>(Pre-sling<br>evaluation)</th><th>Day 14,<br>(1-week with<br>sling evaluation)</th><th>Week 5,<br>(1 month with<br>sling evaluation)</th><th>Δ Day 7 v Day 0</th><th>Δ Week 5 v Day 0</th><th>Δ Week 5 v Day 7</th></tr></thead><tbody><tr><td>Subluxation, cm</td><td></td><td></td><td></td><td></td><td>-0.05 (0.33)</td><td>-0.44 (0.47)</td><td>-0.41 (0.42)</td></tr><tr><td>Mean (SD) [min, max]</td><td>1.68 (1.03)<br>[0, 3]</td><td>1.62 (0.87)<br>[0, 2.7]</td><td>1.52 (0.84)<br>[0, 2.7]</td><td>1.26 (0.83)<br>[0, 2.7]</td><td>P = 0.33<sup>a</sup><br>d = -0.15</td><td>P < 0.001<sup>a</sup><br>d = -0.94</td><td>P < 0.001<sup>a</sup><br>d = -0.98</td></tr><tr><td>Participants analyzed, n</td><td>25</td><td>25</td><td>23</td><td>22</td><td>25</td><td>22</td><td>22</td></tr><tr><td>Pain intensity over the last 24hours, GAS score</td><td>4.6 (3.2)</td><td>3.8 (2.3)</td><td>3.1 (2.6)</td><td>2.7 (2.3)</td><td>-0.8 (2.3)</td><td>-2.1 (3.2)<sup>c</sup></td><td>-1.3 (2.3)<sup>d</sup></td></tr><tr><td>Mean (SD) [min, max]</td><td>[0, 10]</td><td>[0, 8]</td><td>[0, 9]</td><td>[0, 6]</td><td>P = 0.08<sup>b</sup><br>d = -0.35</td><td>P = 0.005<sup>b</sup><br>d = -0.66</td><td>P = 0.01<sup>b</sup><br>d = -0.57</td></tr><tr><td>Participants analyzed, n</td><td>25</td><td>25</td><td>23</td><td>22</td><td>25</td><td>22</td><td>22</td></tr><tr><td>Fugl-Meyer score for the upper extremity,<br>mean (SD) [min, max]</td><td>17.1 (14.9)<br>[0, 45]</td><td>NA</td><td>NA</td><td>28.2 (18.8)<br>[4, 57]</td><td>NA</td><td>9.5 (9.5)<br>P < 0.001<sup>a</sup><br>d = 1.0</td><td>NA</td></tr><tr><td>Participants analyzed, n</td><td>25</td><td>NA</td><td>NA</td><td>21</td><td>NA</td><td>21</td><td>NA</td></tr><tr><td>CAHAI score</td><td>21.4 (15.3)</td><td>23.8 (17.1)</td><td>NA</td><td>33.9 (24.5)</td><td>2.4 (4.9)</td><td>11.9 (14.1)</td><td>9.0 (13.1)</td></tr><tr><td>Mean (SD) [min, max]</td><td>[13, 81]</td><td>[13, 87]</td><td></td><td>[13, 88]</td><td>P = 0.01<sup>a</sup><br>d = 0.49</td><td>P < 0.001<sup>a</sup><br>d = 0.84</td><td>P < 0.001<sup>a</sup><br>d = 0.69</td></tr><tr><td>Participants analyzed, n</td><td>25</td><td>25</td><td>NA</td><td>22</td><td>25</td><td>22</td><td>22</td></tr></tbody></table>

CAHAI, Chedoke Arm and Hand Activity Inventory; d, Cohen’s d effect size = $\frac{X_2-X_1}{\sigma_{X_2-X_1}}$; NA, not applicable (not assessed during visit).

a Wilcoxon Signed-Rank test.

b Paired Student’s t-test.

c Values are -3.0 (2.7) (P = 0.001, d = -1.11) among n = 18 participants with a GAS pain score >0 at day 0.

d Values are 1.7 (1.8) (P < 0.001, d = 0.94) among n = 18 participants with a GAS pain score >0 at day 0 (Wilcoxon Signed-Rank tests).
relevant yet realistic goals and scales. Another drawback lies in subjectivity within personal goal determination and scoring, leading to variation in GAS evaluation, especially when multiple evaluators are involved. Note here that goal determination and scoring were performed for each participant by the same investigative occupational therapists after GAS methodology training. Finally, GAS scoring uses a limited-number ordinal scale, thus reducing sensitivity for measuring subtle changes in goal achievement/failure [16]. These drawbacks can be limited by following specific criteria for goal determination and score descriptions (ie, SMART, specific, measurable, achievable, relevant, and time-specific) [10].

Regarding pain, the mean VAS pain score significantly reduced after 1 month of sling-wearing. We found pain improvement (≥2-VAS score reduction) in 59 % (13/22) of participants, resolution of pain in 14 % (3/22), no pain during the study period in 9 % (2/22), and a deterioration (≥1.5-VAS score increase) in pain in 18 % (4/22) of participants. These findings align with those from Nadler et al. [17]., who reported on changes in HSP between 3 days and 8–10 weeks post-stroke in individuals receiving uncontrolled routine care. Similarly, the authors describe that 13 % of individuals had experienced HSP resolution by 8–10 weeks, while 17 % developed new HSP and 26 % had persistent early-onset HSP. Among our 4 participants experiencing pain worsening, 2 were for unknown reasons, while the other 2 experienced adverse events involving the affected limb (hand edema and wrist tendinitis). One participant also developed algodystrophy, with an improvement in pain throughout the study. All these symptoms are common post-stroke complications, meaning it is difficult to attribute them directly to sling use. Two falls also occurred without incident on upper-limb pain.

The rehabilitation combined with CM sling-wearing for 1 month revealed a clinically significant improvement in upper-limb functional recovery via significantly improved mean Fugl-Meyer (+9.5 points) [18] and mean CAHAI scores. Nonetheless, participants were in the sub-acute stroke phase and thus within the timeframe of fastest spontaneous functional recovery [19,20]. We therefore cannot depict the contribution of the CM sling, but findings at this stage conclude that the CM sling does not hinder functional recovery.

Our study lacked a control group to formally demonstrate the efficacy of our CM sling compared to usual care (a standard non-elastic sling supporting the elbow). Therefore, we are working on validating our results in a larger, controlled study before making recommendations on CM-sling use to all stroke individuals with shoulder subluxation or pain.

## Funding

This study received funding from the Toulouse University Hospital Appel à Projets Recherche et Innovation 2017 scheme (ARI 2017).

## Data statement

Original data are available from the corresponding author on reasonable request.

## Author contributions

E Montané: data collection and interpretation, study supervision, original manuscript drafting; M Pradié: study conception, data collection, study supervision, original manuscript drafting; I Bigarre: data interpretation; C Lebely: study design; A Lelievre: data collection; C Cormier: data interpretation; J Butterworth: data interpretation, original manuscript drafting; B Lepage: methodology and statistical analyses; P Marque: study conception and design, data interpretation; X de Boissezon: study conception and design, data interpretation; E Castel-Lacanal: study conception and design, data interpretation, study supervision, original manuscript drafting. All authors commented on previous manuscript versions and approved this final version.

## Generative AI and AI-assisted technologies

No use of any generative AI or AI-assisted technologies to write this manuscript.

## Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

## Acknowledgments

We thank Mr Thierry Cornier, orthoprothesist technician (OCTO31®, Toulouse, France), for his help with sling design and manufacture, and Dr Aline Meulle, PhD (Institute of Advanced and Surgical Technologies, Toulouse University Hospital, France), for project management. We also thank the occupational therapy team from the Department of Physical and Rehabilitation Medicine (Toulouse, France) for their help with study conduction and sling design. Some of the results of this study were presented as an oral communication at the French Physical Medicine and Rehabilitation Conference (SOFMER) in Le Havre, 2023.

## Supplementary materials

Supplementary material associated with this article can be found in the online version at doi:10.1016/j.rehab.2025.102014.

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